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

NCT06304753 | Completed

• 1 other identifier: BOT119435
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Heart Failure With Low Ejection Fraction

Keywords

heart failure; remote monitoring; adherence; mHealth; telemedicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in NT-proBNP

  an average, 6 months after randomization

• Change in Quality of life

  an average, 6 months after randomization

• Changes in medical adherence

  an average, from 6 weeks to 180 days after randomization

Study Arms (2)

Remote Monitoring

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Telebot DEVICE

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.

Remote Monitoring

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Unwillingness of the patient to continue participating in the study

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (2)

Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University

Moscow, 119435, Russia

Location

State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow".

Moscow, 129327, Russia

Location

Related Publications (3)

• 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.

  PMID: 41925172 RESULT

• 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.

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Aleksei Emelianov

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: October 27, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)