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

Summary

BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes.

Eligibility

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

Conditions2

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