drugset / Trial / NCT06655480
Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF
Phase 2
Recruiting
50 enrolled
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Lomonosov Moscow State University Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2025-03-18
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Finerenone | Small molecule | 20 mg | — |
| Subject | Finerenone | Small molecule | 40 mg | — |
| Subject | Valsartan+Sacubitril | Unknown | 100 mg | — |
| Subject | Valsartan+Sacubitril | Unknown | 200 mg | — |
| Subject | Valsartan+Sacubitril | Unknown | 400 mg | — |
| Background | Empagliflozin | Small molecule | 10 mg | — |