REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor (REMOTE-HEART)

December 7, 2023 updated by: Semmelweis University Heart and Vascular Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

chronic heart failure with reduced ejection fraction (HFrEF) with an implanted CIED (CRT/ICD) eligible for home monitoring

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite of all-cause mortality, heart failure events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cardiovascular hospitalization
Time Frame: 12 months
12 months
cardiovascular mortality
Time Frame: 12 months
12 months
unscheduled visits
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Change in Kansas City Cardiomyopathy Questionnaire score
Time Frame: 12 months
12 months
change of symptoms (assessed by NYHA classification)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4279-1/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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