Clinical trial NCT06304753: ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction
Official title: ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Heart Failure With Low Ejection Fraction
Keywords: heart failure
remote monitoring
adherence
mHealth
telemedicine
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The effectiveness of treatment in patients with chronic heart failure depends on the achievement of target doses of guideline-directed medical therapy. According to the STRONG-HF study, intensive titration for 6 months leads the decrease of hospitalization and mortality. But modern studies shows that only 17% of patients take the four drugs. And the percentage of achievement the target doses is probably even lower. A promising way to solve the problem is remote monitoring. And the investigator developed a program for this. This is a mini-program based on a personal messenger, which is controlled by text commands in a chat on the "question-answer" principle. It allows us to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight) related to heart failure. The pilot trial showed a good program adherence and a significant improvement in quality of life over a three-month period in the remote observation group. BOT-IMPROVE-HF is a multicenter, randomized, parallel group study aimed to evaluate the efficacy and safety of up-titration of heart failure medical therapy including beta-blockers; angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor (ARNi); and mineralocorticoid receptor antagonist (MRAs) using digital remote monitoring. Patients should be admitted for decompensation of chronic heart failure including clinical signs of congestion and elevated circulating N-terminal pro-B-type natriuretic peptide (NT-proBNP), Also they should not get optimal doses of oral heart failure (HF) therapies before discharge. Hemodynamically stable patients will be randomized to either remote monitoring or usual care group. In the first group, repeated assessments of clinical signs and symptoms of heart failure will be collected by a chatbot. Routine clinical laboratory measures including potassium, sodium, and creatinine as well as NT-proBNP will be performed by patients and collected by the chatbot or phone. It will allow us to titrate or continue oral HF therapies. The usual care group will be followed by their general practitioner and/or cardiologist. Patients will be contacted after 6 months to assess outcomes.

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

Primary outcomes:
measure: All-cause mortality
timeFrame: an average, 6 months after randomization
measure: Heart failure decompensation
timeFrame: an average, 6 months after randomization
Secondary outcomes:
measure: Change in NT-proBNP
timeFrame: an average, 6 months after randomization
measure: Change in Quality of life
timeFrame: an average, 6 months after randomization
measure: Changes in medical adherence
timeFrame: an average, from 6 weeks to 180 days after randomization
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow".
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Aleksei Emelianov
role: PRINCIPAL_INVESTIGATOR
References:
citation: Emel'yanov A, Zheleznykh E, Kozhevnikova M, Zektser V, Kamalova A, Privalova E, Belenkov Y. INFLUENCE OF REMOTE DIGITAL OBSERVATIONS ON QUALITY OF LIFE, COMPLIANCE, AND CLINICAL OUTCOMES IN PATIENTS WITH CHRONIC HEART FAILURE. Biomedical Engineering. 2024/01; 57(5):311-315. doi: 10.1007/s10527-023-10322-7.
citation: Emelianov, A. V., Zheleznykh, E. A., Kozhevnikova, M. V., Ageev, A. A., Zektser, V. Y., & Belenkov, Y. N. (2023). Quality of life and adherence to therapy in patients with chronic heart failure who were remotely monitored by chatbot compared to the standard follow-up group for 3 months. Digital Diagnostics, 4(1S), 53-56. doi: 10.17816/DD430343