Actively Recruiting
Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF
Led by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Updated on 2026-04-24
50
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
N
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Lead Sponsor
L
Lomonosov Moscow State University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Symptoms and signs of heart failure
- Left ventricular ejection fraction greater than 50%
- NT-proBNP greater than 300 pg/mL (greater than 900 pg/mL for patients with atrial fibrillation)
- Left ventricular diastolic dysfunction grade II-III OR grade I with at least 2 of 4 specific heart function criteria
- Chronic atrial fibrillation with at least 3 of 4 specific heart function criteria
You will not qualify if you...
- Evidence of myocardial ischemia during stress echocardiography
- Significant lesions of main coronary arteries
- Atrial fibrillation with resting heart rate over 110 beats per minute
- Continuous treatment with ARNI, SGLTi, or MRA for more than 90 days within 12 months before screening
- Coronary bypass surgery, stroke, or TIA within last 3 months
- Myocardial infarction or myocardial revascularization within last 3 months
- Systolic blood pressure less than 90 mmHg or 180 mmHg or higher at screening or randomization
- Genetic forms of HFpEF such as hypertrophic cardiomyopathy, amyloidosis, Fabry disease, or glycogen storage diseases
- Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided heart failure without left-sided disease, constrictive pericarditis, or significant pericardial effusion
- Dyspnea caused by non-cardiac reasons like lung disease, anemia, severe obesity, or primary valve or myocardial diseases
- Severe lung disease requiring home oxygen or chronic oral steroid therapy
- Primary pulmonary artery hypertension
- Significant left-sided structural valve disease
- Anemia with hemoglobin less than 100 g/L
- Obesity with body mass index over 50 kg/m2
- Impaired kidney function with eGFR less than 30 mL/min/1.73 m2
- Impaired liver function with liver enzyme levels above three times the upper limit of normal
- Addison's disease
- Known allergy to medications used in the study
- Non-cardiac conditions that complicate or exclude study participation
- Diseases associated with isolated left ventricular insufficiency like idiopathic pulmonary hypertension or chronic thromboembolic pulmonary hypertension
- Serum or plasma potassium over 5.0 mmol/L at screening or randomization or history of serious hyperkalemia during MRA treatment
- For diabetes patients: type 1 diabetes, more than 4 moderate hypoglycemia episodes in the past month, any severe hypoglycemia within the past year, or glycated hemoglobin outside 6-9% range
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Moscow, Russia
Actively Recruiting
Research Team
A
Artem G Ovchinnikov, MD, PhD, DSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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