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

NCT06655480 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-24

No results posted yet for this study

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

Conditions

  • HFpEF
  • LVDD
  • Myocardial Fibrosis

Interventions

DRUG

[ARNI + SGLTi + AMR]

Empagliflozin 10mg tablet, Valsartan+Sacubitril 100-200-400 mg tablet, Finerenone 20-40 mg tablet

DRUG

[SGLTi + previously taken RAAS blocker]

Empagliflozin 10mg tablet, previously taken RAAS inhibitor

Sponsors & Collaborators

  • Lomonosov Moscow State University Medical Center

    collaborator UNKNOWN

  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655480 on ClinicalTrials.gov