
Search Clinical Trials
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Power Nap With TES-TI
University of Wisconsin, Madison
Non-restorative Sleep
Healthy Volunteer
The goal of this clinical trial is to find out whether stimulating the brain with
electrical current during naps can increase certain kinds of brain activity that happen
during sleep and lead to improvements in mental fatigue.
Participants will attend 2 study visits, each of which may last up to 41 expand
The goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in mental fatigue. Participants will attend 2 study visits, each of which may last up to 4-5 hours. During these visits, participants will wear a high density electroencephalography (hdEEG) cap and take a nap. Type: Interventional Start Date: Dec 2025 |
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CSIMEMPHIS: Long-term Follow-up of Medulloblastoma Survivors That Received Craniospinal Irradiation
St. Jude Children's Research Hospital
Medulloblastoma
The study is being done to learn more about the long-term health and well-being of
participants treated for medulloblastoma. The study is to decide which evaluations
focusing on therapy-related lasting effects (or toxicities) should be considered.
Medulloblastoma outcomes have improved with contem1 expand
The study is being done to learn more about the long-term health and well-being of participants treated for medulloblastoma. The study is to decide which evaluations focusing on therapy-related lasting effects (or toxicities) should be considered. Medulloblastoma outcomes have improved with contemporary therapies including modern neurosurgical techniques and risk-adapted radiotherapy and chemotherapy regimens. However, survivors remain at risk for long-term health problems such as neurocognitive deficits, hearing loss, impaired cardiorespiratory fitness and physical performance, cardiac and neuroendocrine dysfunction, musculoskeletal conditions, and infertility. Type: Observational Start Date: Apr 2026 |
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TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
Treeline Biosciences, Inc.
Lymphoma
Lymphoma, Non Hodgkin
The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and
preliminary anti-tumor activity of TLN-121 as a single agent and in combination with
other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin
Lymphomas expand
The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas Type: Interventional Start Date: Jun 2025 |
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UNTOLD Ovarian Cancer Unmet Needs Survey
Masonic Cancer Center, University of Minnesota
Ovarian Cancer
The goal of this study is to comprehensively measure ongoing concerns and unmet needs of
individuals living with ovarian cancer. To accomplish this, the UNderstanding The
experience of Ovarian cancer - Life after Diagnosis (UNTOLD) study will be conducted
using a mixed-methods approach. Ovarian can1 expand
The goal of this study is to comprehensively measure ongoing concerns and unmet needs of individuals living with ovarian cancer. To accomplish this, the UNderstanding The experience of Ovarian cancer - Life after Diagnosis (UNTOLD) study will be conducted using a mixed-methods approach. Ovarian cancer survivors will be enrolled to participate in UNTOLD to complete a one-time survey regarding their experiences. Up to 40 survivors will be subsequently identified to complete a follow-up interview. To ensure these sample sizes, along with a representative sample, a combined recruitment strategy will be employed using the California Cancer Registry (population-based) and recruitment through ovarian cancer advocacy groups. Type: Observational Start Date: Jul 2025 |
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EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People1
Boehringer Ingelheim
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
This study is open to adults with type 2 diabetes, high blood pressure, and
cardiovascular disease. People can join the study if they have these conditions and do
not have a history of heart failure. The purpose of this study is to find out if a
medicine called vicadrostat, when taken with empaglif1 expand
This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Jul 2025 |
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Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Autolus Limited
Lupus Nephritis
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene
autoleucel (obe-cel) administered once following lymphodepletion in participants with
severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN). expand
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN). Type: Interventional Start Date: Jan 2026 |
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Anifrolumab Pregnancy Study
AstraZeneca
Systemic Lupus Erythematosus
This is a non-interventional multi-database post-authorisation study to assess
pregnancy-related safety data from women with SLE exposed to Anifrolumab. expand
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab. Type: Observational Start Date: Jun 2026 |
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Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hi1
Incyte Corporation
Hidradenitis Suppurativa
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult
and adolescent participants with hidradenitis suppurativa. expand
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa. Type: Interventional Start Date: Nov 2025 |
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Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women
Johns Hopkins University
Hypertension
CROWN is a two-arm, cluster-randomized pilot trial testing the feasibility and
preliminary efficacy of a salon-based cardiovascular intervention - training stylists as
Heart Health Stylists to conduct in-salon blood pressure screenings, home monitoring with
telehealth support, community health-work1 expand
CROWN is a two-arm, cluster-randomized pilot trial testing the feasibility and preliminary efficacy of a salon-based cardiovascular intervention - training stylists as Heart Health Stylists to conduct in-salon blood pressure screenings, home monitoring with telehealth support, community health-worker coaching, and pharmacist-led medication management - among Black and Hispanic women with hypertension. Type: Interventional Start Date: Jul 2026 |
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This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821491
Pfizer
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Hormone Sensitive Prostate Cancer
Prostate Cancer
Cancer of the Prostate
This study will explore whether a combination of the investigational drug mevrometostat
(PF-06821497) and enzalutamide will work better than taking enzalutamide alone in
participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the
mCSPC setting. expand
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting. Type: Interventional Start Date: Sep 2025 |
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A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexp1
Incyte Corporation
Ovarian Cancer
This study will evaluate the safety and efficacy of INCB123667 in Participants With
Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression. expand
This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression. Type: Interventional Start Date: Nov 2025 |
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A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention1
City of Hope Medical Center
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
This phase Ib trial tests the safety, side effects, and how well cytomegalovirus
(CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific
immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic
stem cell transplant. Haploidentical stem cel1 expand
This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and/or effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT. Type: Interventional Start Date: May 2026 |
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Intestinal Microbiome Transplant in ALS
Duke University
Amyotrophic Lateral Sclerosis ALS
This is a 24-week study of intestinal microbiome transplant in people with ALS. All
participants will be evaluated clinically in person for 4 visits. Blood and mailed/ fresh
stool samples will also be collected. Blood samples will be used to determine changes in
neurofilament light chain over time.1 expand
This is a 24-week study of intestinal microbiome transplant in people with ALS. All participants will be evaluated clinically in person for 4 visits. Blood and mailed/ fresh stool samples will also be collected. Blood samples will be used to determine changes in neurofilament light chain over time. Stool samples will be processed for microbiome analysis. Participants will have phone visits to further evaluate safety and tolerability. They will then undergo antibiotic conditioning and a standard bowel preparation before being assigned to the investigational product, MTP-101C . Type: Interventional Start Date: Jan 2026 |
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Implementation of an Oral Chemotherapy Adherence Intervention
UNC Lineberger Comprehensive Cancer Center
Solid Tumor
Hematologic Malignancy
The goal of this study is to evaluate the effectiveness and usability of a newly
developed oral anticancer agent adherence program implemented across 6 cancer clinics
(two academic, two urban, and two rural). The study will include 160 adult participants
with either solid tumors or hematologic mali1 expand
The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). The study will include 160 adult participants with either solid tumors or hematologic malignancies who have been taking oral anticancer agents for at least six months. This study will have two groups of participants, a pre- and post-implementation group. In the pre-implementation of the program group, investigators will administer a survey to the 80 participants and gather information about their medication prior to their enrollment of the program. Similarly, 80 participants who have been enrolled into this program for at least 6 months will serve as the post-implementation group. These patients will be administered the same survey. The results from both groups will be analyzed to see how effective the medication adherence program is. Type: Interventional Start Date: May 2025 |
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A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spr1
Pfizer
Cachexia
Metastatic Pancreatic Ductal Adenocarcinoma
Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus
ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in
adult participants with cachexia and metastatic pancreatic ductal adenocardinoma. expand
Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma. Type: Interventional Start Date: Oct 2025 |
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Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Adva1
Relay Therapeutics, Inc.
PIK3CA Mutation
HER2- Negative Breast Cancer
Hormone Receptor Positive Tumor
Breast Cancer
Metastatic Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the
efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the
treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or
progression on or after treatment with a CDK4/61 expand
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor. Type: Interventional Start Date: Aug 2025 |
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Tibial IMN Vs. Tibial Micromotion IMN
University of Chicago
Tibial Fracture
Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not
impact union or complication rates when compared to standard of care treatment with
non-micromotion tibial nail fixation. There are no current or past randomized controlled
trials comparing these fixation techniq1 expand
Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not impact union or complication rates when compared to standard of care treatment with non-micromotion tibial nail fixation. There are no current or past randomized controlled trials comparing these fixation techniques to one another. There is good data supporting both the use of intramedullary fixation for tibial fractures alone, and in high-risk patient populations (open fractures, GSW tibial fractures). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications. With much of the limited existing literature on tibial nails being in very defined populations, without a strong comparison group there is no clear guidance on when the use of a micromotion device is indicated. Our approach to randomize our patients will reduce the bias that exists in the current literature and provide a robust spectrum of injuries to sub analyze and compare. Objectives Primary Objective Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices. Secondary Objective(s) Compare complication rates, patient reported outcomes, range of motion, pain and radiographic/sonographic outcomes in patients treated with tibial nails. Type: Interventional Start Date: Jul 2025 |
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Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Ca1
Abiomed Inc.
AMI Cardiogenic Shock
The observational study titled "Observational Assessment of Support with Impella Best
Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)"
aims to evaluate the safety outcomes of patients with acute myocardial infarction
complicated by cardiogenic shock (AMICS) w1 expand
The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 <55% with a normal PaO2) and systolic blood pressure <100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant. Type: Observational [Patient Registry] Start Date: Jul 2025 |
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Cervical Ripening Balloons for Same-Day Cervical Prep
University of New Mexico
Dilation and Evacuation
The goal of this clinical trial is to learn if a cervical ripening balloon (Foley
balloon) works to prepare the cervix before same-day outpatient dilation and evacuation
(D&E). The main questions it aims to answer are:
- Is cervical preparation with cervical ripening balloon for same-day outpat1 expand
The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D&E). The main questions it aims to answer are: - Is cervical preparation with cervical ripening balloon for same-day outpatient D&E non-inferior to cervical preparation with osmotic dilators? - How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D&E? - How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D&E? Participants will: - Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) - Complete two surveys, one about the cervical preparation and one about the D&E procedure Type: Interventional Start Date: Apr 2025 |
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Alzheimer's Tau Platform: Master Protocol
Paul S. Aisen
Preclinical Alzheimer's Disease
Alzheimer Disease
Prodromal Alzheimer's Disease
The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and
effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid
monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early
prodromal Alzheimer's disease.
This platform trial1 expand
The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol. This means that multiple investigational products will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. The main questions the platform trial aims to answer are: - Does a tau-directed therapy, alone or in combination with donanemab, reduce tau buildup in the brain compared to donanemab alone? - Does a tau-directed therapy, alone or in combination with donanemab, slow disease progression based on brain imaging, fluid biomarkers, and measures of memory and thinking? Participants will: - Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time. - Receive donanemab or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with donanemab. - Undergo regular cognitive testing, brain scans (MRI/PET), and biomarker assessments over 30 months Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of donanemab and tau therapy, or (3) donanemab alone. New regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available. ATP will launch with one regimen: Regimen A: AADvac1. In the future, Regimen B ("Tau2") will launch with a second tau directed therapy. Type: Interventional Start Date: Jul 2026 |
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A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Dise1
BlueRock Therapeutics
Parkinsons Disease (PD)
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled,
double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102
adults with Parkinson's Disease (PD). expand
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD). Type: Interventional Start Date: Jun 2025 |
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Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Ado1
Baylor College of Medicine
Obesity and Type 2 Diabetes
Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social
determinants of health (SDoH) serve as barriers to behavior change and participation in
disease prevention efforts, especially among vulnerable adolescents. Telehealth is a
potentially effective approach for deliv1 expand
Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents. Telehealth is a potentially effective approach for delivering disease prevention programs as it addresses some SDoH like transportation, childcare needs, and parent work schedules. Unfortunately, there are no theory- or evidence-based telehealth diabetes prevention program for Hispanic adolescents. Therefore the purpose of this study is to adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity. Type: Interventional Start Date: Apr 2025 |
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Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Agitated Solutions, Inc.
Right-To-Left Shunt
This is a phase 3, multicenter, open-label, blinded, crossover trial in which each
participant will undergo a randomized sequence of ASI-02 and agitated saline standard of
care (SoC) via a saline contrast transthoracic echocardiogram (TTE) study. expand
This is a phase 3, multicenter, open-label, blinded, crossover trial in which each participant will undergo a randomized sequence of ASI-02 and agitated saline standard of care (SoC) via a saline contrast transthoracic echocardiogram (TTE) study. Type: Interventional Start Date: Nov 2025 |
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Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to S1
Eli Lilly and Company
Ulcerative Colitis
Obesity or Overweight
The main purpose of this study is to show whether in these individuals, treatment with
both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo,
leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the
overall body weight.
Participation1 expand
The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment. Type: Interventional Start Date: Jun 2025 |
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A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With1
Boehringer Ingelheim
Heart Failure
This study is open to adults with chronic heart failure (HF) who have a reduced left
ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they
have been diagnosed with chronic HF at least 3 months before they start on the study. The
purpose of this study is to find ou1 expand
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: May 2025 |