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NOT YET RECRUITING
NCT06655480
PHASE2

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

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

View on ClinicalTrials.gov

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

Official title: Effect on Clinical Status, Structural and Functional Cardiac Parameters and Myocardial Fibrosis of Triple Combination Therapy With a Sodium-glucose Cotransporter 2 Inhibitor, Angiotensin Receptor/Neprilysin Inhibitor and Mineralocorticoid Receptor Antagonist in Patients With Advanced HFpEF

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-03-18

Completion Date

2026-12-31

Last Updated

2025-02-19

Healthy Volunteers

No

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