Clinical trial NCT06173089: REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
Official title: REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: remote monitoring
home monitoring
heart failure
cardiac resynchronization therapy
implantable cardioverter defibrillator
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: chronic heart failure with reduced ejection fraction (HFrEF) with an implanted CIED (CRT/ICD) eligible for home monitoring

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The composite of all-cause mortality, heart failure events
timeFrame: 12 months
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: 12 months
measure: cardiovascular hospitalization
timeFrame: 12 months
measure: unscheduled visits
timeFrame: 12 months
Other outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire score
timeFrame: 12 months
measure: change of symptoms (assessed by NYHA classification)
timeFrame: 12 months
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University - Heart and Vascular Center
Study officials:
References: