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 range40 Years ā 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
ā. Evidence of myocardial ischemia during stress echocardiography;
ā. Significant lesions of main coronary arteries;
ā. Atrial fibrillation with resting HR \> 110 beats/min;
ā. 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.
ā. Coronary bypass surgery, stroke or TIA within the last 3 months of screening;
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