CompletedNANCT06304753

ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction

Sponsor: I.M. Sechenov First Moscow State Medical University

Trial Details

ConditionChronic Heart Failure With Low Ejection Fraction
InterventionTelebot
PhaseNA
StatusCompleted
Participants66
Est. Completion1 June 2025
Last Updated26 May 2026

Primary Outcome

All-cause mortality; Heart failure decompensation

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * Age \> 18 and \< 85 years * HFrEF diagnosed according to 2020 Clinical practice guidelines for Chronic heart failure of Russian Society of Cardiology (RSC) * Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation. * Stable condition at the time of discharge from the hospital * All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm. * All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mmol/L. * At the moment of Randomization either (a) \<= ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and \<= ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, \<= ½ the optimal dose of beta-blocker prescribed, and \<= ½ the optimal dose of MRA prescribed. * A smartphone with Internet access * Written informed consent to participate in the study. Non-inclusion Criteria: * Age \< 18 or \> 85 years. * Stroke or transient ischemic attack (TIA) within the 3 months prior to Screening. * Primary liver disease considered to be life threatening. * Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated white blood cells (WBC) or need for intravenous antibiotics. * Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months. * Alcohol or drug abuse * Pregnant or nursing (lactating) women. * Serious vision and/or hearing problems * Renal disease or estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 \[as estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or the simplified Modification of Diet in Renal Disease (MDRD) formula\] at Screening or history of dialysis. * Clearly documented intolerance or contraindication to any of beta-blockers, renin-angiotensin system (RAS) blockers (both ACEi and ARB), angiotensin receptor neprilysin inhibitor (ARNi), mineralocorticoid receptor antagonist (MRAs). * Significant pulmonary disease contributing substantially to the patients' dyspnea such as forced expiratory volume during the 1st second (FEV1)\< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism. * Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening. * Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy. * History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device. * Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures Exclusion Criteria: * Unwillingness of the patient to continue participating in the study * The development of conditions related to the criteria of non-inclusion

Trial Sites

Countries

Russia
View Registry Entry

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