Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF
Russia50 participantsStarted 2025-03-18
Plain-language summary
Patients with advanced heart failure with preserved ejection fraction (HFpEF) will be randomly assigned in open-label multicenter study to receive triple combination therapy with \[angiotensin receptor/neprilysin inhibitor \[ARNI\] + sodium-glucose cotransporter 2 inhibitor \[SGLTi\] + mineralocorticoid receptor antagonist \[MRA\]) or with individualized medical therapy \[SGLTi + renin-angiotensin system inhibitor \[RASi\] \[angiotensin receptor blocker \[ARB\] or angiotensin-converting enzyme inhibitor \[ACE-I\]), and will be treated for 52 weeks
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Evidence of myocardial ischemia during stress echocardiography;
. Significant lesions of main coronary arteries;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in myocardial extracellular volume (MRI)
Timeframe: 52 weeks
2
Change in 6-minute walking distance (6MWD)
Timeframe: 52 weeks
3
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)
Timeframe: 52 weeks
4
Change in average E/e' ratio and tricuspid regurgitation velocity
Timeframe: 52 weeks
5
Change in left atrial volume index (LAVi)
Timeframe: 52 weeks
Trial details
NCT IDNCT06655480
SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation
. Atrial fibrillation with resting HR \> 110 beats/min;
. 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.
. Coronary bypass surgery, stroke or TIA within the last 3 months of screening;
. Myocardial infarction or myocardial revascularization within the last 3 months of screening;
. Systolic blood pressure \< 90 mmHg or ≥ 180 mmHg at screening or randomization;
. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);