Triple drug combo aims to reverse heart scarring in stiff heart failure
NCT ID NCT06655480
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 Hide 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%
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HFPEF are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
RECRUITINGMoscow, Russia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One scan to rule them all? new CT aims to replace multiple heart tests
- Hormone therapy may shield menopausal hearts and brains — a trial puts it to the test
- Heart failure clues: study tracks 500 patients for 3 years
- New contrast agent could mean lower doses for heart MRI
- Smartphone coaching aims to reverse heart damage from high blood pressure
- Blood pressure drug may shield hearts during breast cancer radiation