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New treatment option for HFpEF
Official title Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF
ClinicalTrials.gov ID: NCT06655480
What this study is testing
What is [ARNI + SGLTi + AMR]?
[ARNI + SGLTi + AMR] is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hfpef.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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)
- LV diastolic dysfunction II-III grade OR LV diastolic dysfunction I grade and at least 2 out of 4:
You likely can't join if
- 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...
- Coronary bypass surgery, stroke or TIA within the last 3 months of screening;
- Myocardial infarction or myocardial revascularization within the last 3 months of screening;
See the full eligibility criteria
- 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)
- LV diastolic dysfunction II-III grade OR LV diastolic dysfunction I grade and at least 2 out of 4:
- Е/е' \> 14
- LAVi \> 34 ml/m2 (for those with persistent atrial fibrillation \> 40 ml/m2)
- PASP \> 35 mm Hg or TR velocity \> 2.8 m/sec
- LV mass index \> 95 g/m2 for women / \> 115 g/m2 for men or LV interventricular septum or posterior wall thickness ≥ 1.1 sm OR Chronic atrial fibrillation and at least 3 out of 4:
- Е/е' \> 11
- E-wave velocity \> 100 sm/s
- TR velocity \> 2.8 sm/s
- DT ≤ 160 ms
- 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...
- Coronary bypass surgery, stroke or TIA within the last 3 months of screening;
- Myocardial infarction or myocardial revascularization within the last 3 months of screening;
- Systolic blood pressure \< 90 mmHg or ≥ 180 mmHg at screening or randomization;
- Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);
- Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;
- Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;
- Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);
- Primary pulmonary artery hypertension;
- Significant left sided structural valve disease;
- Anemia (Hb \< 100 g/L);
- Obesity (body mass index \> 50 kg/m2);
- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (CKD-EPI);
- Impaired liver function (serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 × upper limit of normal);
- Addison's disease;
- Known hypersensitivity to medications used the in the study;
- Non-cardiac conditions that complicate/exclude participation in the study;
- Diseases associated with isolated LV insufficiency (idiopathic pulmonary hypertension, chronic thromboembolic pulmonary hypertension, etc.);
- Serum/plasma potassium \>5.0 mmol/L at screening or randomization or a history of hyperkalemia or acute renal failure during AMR treatment for \>7 consecutive days leading to discontinuation of AMR treatment.
- For patients with diabetes mellitus:
- Type 1 diabetes mellitus;
- Presence of more than 4 episodes of moderate hypoglycemia within the past month or at least one episode of severe hypoglycemia within the past year;
- Glycated hemoglobin level \> 9% or \<6%
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.