RecruitingNot ApplicableNCT06304753

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

Sponsor

I.M. Sechenov First Moscow State Medical University

Enrollment

60 participants

Start Date

Oct 27, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether digital remote monitoring — using apps or devices to track health data at home — helps doctors better manage heart failure treatment in people whose hearts pump less blood than normal (called heart failure with reduced ejection fraction). **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with heart failure with reduced ejection fraction (HFrEF) - You were recently hospitalized for acute heart failure with breathlessness or fluid buildup - Your blood pressure and heart rate are stable at discharge - Your potassium levels are within a safe range - You are on heart failure medications (ACE inhibitors, ARBs, or similar) at less than or equal to half the optimal dose **You may NOT be eligible if...** - Your condition is not stable enough at discharge - Your blood pressure, heart rate, or potassium levels fall outside the required ranges - You are not able to use a digital monitoring app Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETelebot

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.

Locations(2)

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

Moscow, Russia

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

Moscow, Russia

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NCT06304753