ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction (BOT-IMPROVE-HF)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure With Low Ejection Fraction
• Intervention / Treatment: Device: Telebot

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 119435
    • Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University
  • Moscow, Russia, 129327
    • State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow".

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Monitoring; Patients with chronic heart failure with low ejection fraction who was hospitalized due to decompensation of their condition. Their condition should be stabilized and blood pressure and renal function (Potassium level and eGFR) should be sufficient for titration of drugs. They should also have a smartphone with internet access. Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 6 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.	Device: Telebot; 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. Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 6 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.
No Intervention: Usual Care; Patients with chronic heart failure with low ejection fraction who was hospitalized due to decompensation of their condition. Their condition should be stabilized and blood pressure and renal function (Potassium level and eGFR) should be sufficient for titration of drugs. They should also have a smartphone with internet access. Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Mortality rate	an average, 6 months after randomization
Heart failure decompensation	Frequency of worsening heart failure leads to hospitalization or administration of parenteral loop diuretics	an average, 6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NT-proBNP	Change in NT-proBNP on the log scale	an average, 6 months after randomization
Change in Quality of life	Change in quality of life as measured using the The Minnesota living with heart failure questionnaire (MLHFQ) scale which ranges from 0 to 100 with a higher score representing a better outcome.	an average, 6 months after randomization
Changes in medical adherence	Change in amount of taking drugs and doses with a higher score representing a better outcome	an average, from 6 weeks to 180 days after randomization

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Aleksei Emelianov, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

General Publications

• 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.
• 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
• Kozhevnikova MV, Emelianov AV, Zheleznykh EA, Pavlov NA, Khabarova NV, Belenkov YN. Impact of Digital Remote Monitoring on the Optimization of Guideline-Directed Medical Therapy Titration in Heart Failure With Reduced Ejection Fraction. Kardiologiia. 2026 Apr 2;66(2):21-30. doi: 10.18087/cardio.2026.2.n3105. English, Russian.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: adherence; telemedicine; heart failure; mHealth; remote monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: BOT119435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the Local Ethics Committee's rules, we are not allowed to provide this data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No