REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

Heart Failure Clinical Trial

— REMOTE-HEART  

Official title:

REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173089
• Other study ID #: 4279-1/2022
• Status: Recruiting
• Start date: January 30, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: January 2023
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events. The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class. By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated. Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: August 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. CRT-P/CRT-D patients with a feasible device for home monitoring

2. ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring

3. SR/AFib

4. Transmission performance >80% in the first 2 weeks with new device

5. Informed consent

Exclusion Criteria:

1. Life expectancy<1 year

2. Unable to transmit data

3. Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts

4. Expected non-compliance

5. Pregnancy

6. Known drug, alcohol abuse

7. Participation in other study or HM system concept

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Remote monitoring
Remote monitoring for patients with an ICD/CRT device

Locations

Country	Name	City	State
Hungary	Semmelweis University - Heart and Vascular Center	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Kansas City Cardiomyopathy Questionnaire score		12 months
Other	change of symptoms (assessed by NYHA classification)		12 months
Primary	The composite of all-cause mortality, heart failure events		12 months
Secondary	cardiovascular mortality		12 months
Secondary	cardiovascular hospitalization		12 months
Secondary	unscheduled visits		12 months