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Triple drug combo aims to reverse heart scarring in stiff heart failure

NCT ID NCT06655480

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a three-drug combination (SGLT2 inhibitor, ARNI, and MRA) can improve heart structure, function, and symptoms in 50 people with advanced HFpEF, a type of heart failure where the heart is stiff but pumps normally. Participants will receive either the triple therapy or standard care for 52 weeks. The goal is to see if the combination reduces heart scarring and improves exercise ability and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed and data informed consent; 2. Symptoms and signs of HF; 3. LV ejection fraction \> 50%; 4. NT-proBNP \> 300 pg/mL (for patients with atrial fibrillation NT-proBNP \> 900 pg/mL) 5. LV diastolic dysfunction II-III grade OR LV diastolic dysfunction I grade and at least 2 out of 4: * Е/е' \> 14 * LAVi \> 34 ml/m2 (for those with persistent atrial fibrillation \> 40 ml/m2) * PASP \> 35 mm Hg or TR velocity \> 2.8 m/sec * LV mass index \> 95 g/m2 for women / \> 115 g/m2 for men or LV interventricular septum or posterior wall thickness ≥ 1.1 sm OR Chronic atrial fibrillation and at least 3 out of 4: * Е/е' \> 11 * E-wave velocity \> 100 sm/s * TR velocity \> 2.8 sm/s * DT ≤ 160 ms Exclusion Criteria: 1. Evidence of myocardial ischemia during stress echocardiography; 2. Significant lesions of main coronary arteries; 3. Atrial fibrillation with resting HR \> 110 beats/min; 4. Continuous (\>90 days) treatment with ARNI, SGLTi and/or AMR within 12 months prior to screening. The last administration of these drugs must be at least 30 days prior to randomization. Treatment with these drugs should not be interrupted for the purpose of inclusion in the study. 5. Coronary bypass surgery, stroke or TIA within the last 3 months of screening; 6. Myocardial infarction or myocardial revascularization within the last 3 months of screening; 7. Systolic blood pressure \< 90 mmHg or ≥ 180 mmHg at screening or randomization; 8. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.); 9. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion; 10. Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases; 11. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy); 12. Primary pulmonary artery hypertension; 13. Significant left sided structural valve disease; 14. Anemia (Hb \< 100 g/L); 15. Obesity (body mass index \> 50 kg/m2); 16. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (CKD-EPI); 17. Impaired liver function (serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 × upper limit of normal); 18. Addison's disease; 19. Known hypersensitivity to medications used the in the study; 20. Non-cardiac conditions that complicate/exclude participation in the study; 21. Diseases associated with isolated LV insufficiency (idiopathic pulmonary hypertension, chronic thromboembolic pulmonary hypertension, etc.); 22. Serum/plasma potassium \>5.0 mmol/L at screening or randomization or a history of hyperkalemia or acute renal failure during AMR treatment for \>7 consecutive days leading to discontinuation of AMR treatment. 23. For patients with diabetes mellitus: * Type 1 diabetes mellitus; * Presence of more than 4 episodes of moderate hypoglycemia within the past month or at least one episode of severe hypoglycemia within the past year; * Glycated hemoglobin level \> 9% or \<6%

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

    RECRUITING

    Moscow, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.