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Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Sep 1, 2026 to Dec 31, 2027
    • Study sites: 0 to 1
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v5
  2. Start date: Feb 18, 2025 to Mar 18, 2025v4
  3. Start date: Dec 18, 2024 to Feb 18, 2025v3
  4. Start date: Oct 30, 2024 to Dec 18, 2024
    • Secondary endpoints: 4 to 9
    • Collaborator revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06655480
Lead Sponsor National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Collaborators: Lomonosov Moscow State University Medical Center
Conditions
(from sponsor)		 HFpEF, LVDD, Myocardial Fibrosis
Related terms Hypertrophy, Left Ventricular
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov