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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation

About this trial

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

Eligibility criteria

Qualifiers

Signed and data informed consent;

Symptoms and signs of HF;

LV ejection fraction > 50%;

NT-proBNP > 300 pg/mL (for patients with atrial fibrillation NT-proBNP > 900 pg/mL)

Disqualifiers

Evidence of myocardial ischemia during stress echocardiography;

Significant lesions of main coronary arteries;

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.

Trial design

Treatments tested in this trial

  • [ARNI + SGLTi + AMR]
  • [SGLTi + previously taken RAAS blocker]

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators