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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University
RECRUITING
Moscow
State Budgetary Institution of Healthcare of Moscow A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow.
RECRUITING
Moscow
Contact Information
Primary
Maria Kozhevnikova
kozhevnikova_m_v@staff.sechenov.ru
+7 (499) 248-46-43
Backup
Aleksei Emelianov
emelyanov_a_v@staff.sechenov.ru
+7 (999) 830-57-85
Time Frame
Start Date: 2023-10-27
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 60
Treatments
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.
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
Related Therapeutic Areas
Sponsors
Leads: I.M. Sechenov First Moscow State Medical University

This content was sourced from clinicaltrials.gov