[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lvdd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lvdd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100566461","phase-2-triple-combination-therapy-arni-sglt2i-mra-in-advanced-hfpef-100566461",false,"NCT06655480","Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF","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\u002FNeprilysin Inhibitor and Mineralocorticoid Receptor Antagonist in Patients With Advanced HFpEF","Inclusion Criteria:\n\n1. Signed and data informed consent;\n2. Symptoms and signs of HF;\n3. LV ejection fraction \\> 50%;\n4. NT-proBNP \\> 300 pg\u002FmL (for patients with atrial fibrillation NT-proBNP \\> 900 pg\u002FmL)\n5. LV diastolic dysfunction II-III grade OR\n\nLV diastolic dysfunction I grade and at least 2 out of 4:\n\n* Е\u002Fе' \\> 14\n* LAVi \\> 34 ml\u002Fm2 (for those with persistent atrial fibrillation \\> 40 ml\u002Fm2)\n* PASP \\> 35 mm Hg or TR velocity \\> 2.8 m\u002Fsec\n* LV mass index \\> 95 g\u002Fm2 for women \u002F \\> 115 g\u002Fm2 for men or LV interventricular septum or posterior wall thickness ≥ 1.1 sm OR\n\nChronic atrial fibrillation and at least 3 out of 4:\n\n* Е\u002Fе' \\> 11\n* E-wave velocity \\> 100 sm\u002Fs\n* TR velocity \\> 2.8 sm\u002Fs\n* DT ≤ 160 ms\n\nExclusion Criteria:\n\n1. Evidence of myocardial ischemia during stress echocardiography;\n2. Significant lesions of main coronary arteries;\n3. Atrial fibrillation with resting HR \\> 110 beats\u002Fmin;\n4. Continuous (\\>90 days) treatment with ARNI, SGLTi and\u002For 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 not be interrupted for the purpose of inclusion in the study.\n5. Coronary bypass surgery, stroke or TIA within the last 3 months of screening;\n6. Myocardial infarction or myocardial revascularization within the last 3 months of screening;\n7. Systolic blood pressure \\\u003C 90 mmHg or ≥ 180 mmHg at screening or randomization;\n8. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);\n9. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;\n10. Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases;\n11. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);\n12. Primary pulmonary artery hypertension;\n13. Significant left sided structural valve disease;\n14. Anemia (Hb \\\u003C 100 g\u002FL);\n15. Obesity (body mass index \\> 50 kg\u002Fm2);\n16. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI);\n17. Impaired liver function (serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 × upper limit of normal);\n18. Addison's disease;\n19. Known hypersensitivity to medications used the in the study;\n20. Non-cardiac conditions that complicate\u002Fexclude participation in the study;\n21. Diseases associated with isolated LV insufficiency (idiopathic pulmonary hypertension, chronic thromboembolic pulmonary hypertension, etc.);\n22. Serum\u002Fplasma potassium \\>5.0 mmol\u002FL 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.\n23. For patients with diabetes mellitus:\n\n    * Type 1 diabetes mellitus;\n    * 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;\n    * Glycated hemoglobin level \\> 9% or \\\u003C6%","ALL","40 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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\u002Fneprilysin 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",[27,28,29],"HFpEF","LVDD","Myocardial Fibrosis",[27,31,32,33,34,35,36],"HF","left ventricular hypertrophy","diastolic dysfunction","cardiac reserves","LV filling pressures","myocardial fibrosis","RECRUITING","2026-04-21",{"date":40,"type":41},"2026-04-24","ACTUAL",{"date":43,"type":41},"2025-03-18",{"date":45,"type":21},"2027-12-31",{"name":47,"class":48},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","OTHER_GOV"]