Improving heart failure treatment with digital remote monitoring

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

This study tests if using digital remote monitoring can help people with chronic heart failure get better treatment and feel healthier after they leave the hospital.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: I.M. Sechenov First Moscow State Medical University (other)
• Locations: 2 sites (Moscow and 1 other locations)
• Trial ID: NCT06304753 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of using digital remote monitoring to enhance the treatment of patients with chronic heart failure and low ejection fraction after hospitalization. Patients will be randomly assigned to either a remote monitoring group, where their health data will be collected through a mini-program on a messaging platform, or a usual care group managed by their healthcare providers. The remote monitoring approach aims to facilitate timely adjustments to medication dosages based on real-time health data, potentially improving patient outcomes. The follow-up period for assessing treatment effectiveness will last for 6 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with chronic heart failure and low ejection fraction who have been recently hospitalized for heart failure decompensation.

Not a fit: Patients who are not hospitalized for heart failure or those with stable chronic heart failure not requiring medication adjustments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better management of heart failure, reducing hospitalizations and improving patients' quality of life.

How similar studies have performed: Previous studies have shown promising results with remote monitoring approaches in managing heart failure, indicating potential for success in this study.

Eligibility 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

Where this trial is running

Moscow and 1 other locations

• Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University — Moscow, Russian Federation (RECRUITING)
• State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow". — Moscow, Russian Federation (RECRUITING)

Study contacts

• Principal investigator: Aleksei Emelianov — I.M. Sechenov First Moscow State Medical University (Sechenov University)
• Study coordinator: Maria Kozhevnikova

Conditions: Chronic Heart Failure With Low Ejection Fraction, heart failure, remote monitoring, adherence, mHealth, telemedicine