Haemodynamics and Ventricular Arrhythmias During Exercise in Patients With Arrhythmogenic Cardiomyopathy

March 15, 2026 updated by: Technical University of Munich

Haemodynamics and Ventricular Arrhythmias During Moderate-intensity Endurance and Resistance Exercise in Patients With Arrhythmogenic Cardiomyopathy, a Pilot Study

Patients with definitive and borderline arrhythmogenic cardiomyopathy (ACM) are usually recommended to refrain from high intensity exercise due to an increased risk of malignant arrhythmias. However, little is known about the effects of prolonged, low-to moderate endurance or resistance exercise on the burden of arrhythmias or central haemodynamics. This pilot interventional study assesses the impact of these modes of exercise on the electrophysiological substrate of the right ventricle (RV), measured by mapping of the RV, and central haemodynamics assessed by right heart catheterization. Patients older than 18 years of age with diagnosed borderline and definitive ACM are included with or without implantable cardioverter-defibrillator (ICD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a one-armed, monocentric, unblinded pilot interventional study. Upon fulfilment of the inclusion criteria (age >18 years of age, diagnosis of definitive or borderline ACM with or without implantable cardioverter defibrillator, ICD) and informed consent, patients will have two visits within one week.

The baseline exam (V1), consists of a clinical history, a questionnaire on the quality of life (Kansas City Cardiomyopathy Questionnaire, KCCQ), laboratory examination, echocardiography, 24h-Holter monitoring, and exertional cardiopulmonary exercise testing (CPET). Morphological (echocardiography) and functional (CPET) capacity of the participants will be assessed. With the aid of CPET, exercise intensity for continuous low to moderate-intensity endurance exercise during exercise right heart catheterization (exRHC) will be assessed (power at first ventilatory threshold). During V1 the one repetition maximum (1RPM) of isometric handgrip strength will be assessed as well as during dynamic flexion of the upper arm (biceps curl) with the contralateral arm of the planned venous puncture during the invasive testing.

Invasive Testing (V2): V2 will follow 48 hours after V1. Patients will first undergo supine resting right heart catheterization (RHC) followed by an electrophysiological study with mapping of the right ventricle (RV mapping) (condition 1, rest). Access for both procedures will be gained via the right internal jugular or brachial vein. After a 5-minute break isometric handgrip testing will assess haemodynamic changes (condition 2, isometric resistance test at 70% of the 1RPM for one minute). After another 5-minute break dynamic resistance testing will assess haemodynamic alterations (condition 3, dynamic resistance test, biceps curl at 70% of 1RPM for one minute with the contralateral arm of venous puncture). Following another 5-minute break, patients will perform supine bicycle exercise testing and haemodynamic measurements will be obtained at the end of 20 minutes of continuous, low to moderate-intensity endurance exercise (power at the first ventilatory threshold, condition 4, 20 minutes of moderate-intensity endurance test). Following haemodynamic testing, a prolonged low to moderate-intensity endurance exercise test will follow for another 20 minutes (power at the first ventilatory threshold), leading to a total time of 40 minutes, which is double the recommended duration from sports cardiology guidelines. Assessment of haemodynamics and RV mapping will be done at the end of this test (condition 5, 40-minutes low to moderate-intensity endurance test). In addition, cardiac biomarkers will be assessed before and after exercise.

Following invasive testing, patients without an ICD will receive an implantable loop recorder (ILR).

The aim of this interventional study is to assess changes of voltage maps during each of the exercise modes (20 minutes endurance test vs. 40 minutes endurance test vs. isometric handgrip vs. dynamic resistance exercise) as well as the change of pulmonary pressures. As patients with an ICD represent a high risk category, electrical and haemodynamic properties are compared between groups (ICD yes vs. no) in an exploratory approach. In this interventional study, which consists of assessments which are not part of routine medical care, the haemodynamic and electrophysiological effects of different exercise interventions (endurance and resistance tests) are evaluated.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

  • Germany
      • München, Germany, 81675
        • Technische Universität München

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

Description

Inclusion Criteria:

  • Age >18 years of age
  • Diagnosis of definitive or borderline arrhythmogenic cardiomyopathy (ACM) with or without implantable cardioverter defibrillator (ICD)

Exclusion Criteria:

  • Age <18 years of age
  • Manifest acute heart failure
  • Intracardiac shunts
  • Pre-existing precapillary pulmonary hypertension
  • Clinical suspicion of new coronary artery disease or disease progression
  • More than grade II valvular heart disease at resting echocardiography

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1 with implantable cardioverter-defibrillator
Patients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy and implantable cardioverter-defibrillator will be included.
Other: Resting and exercise right heart catheterization
At rest and after different modes of exercise, exercise right heart catheterization will be performed.
Other: Right ventricular mapping
At the beginning and at the end of the exercise modes right ventricular mapping will be performed.
Other: Group 2 without implantable cardioverter-defibrillator
Patients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy without implantable cardioverter-defibrillator will be included.
Other: Resting and exercise right heart catheterization
At rest and after different modes of exercise, exercise right heart catheterization will be performed.
Other: Right ventricular mapping
At the beginning and at the end of the exercise modes right ventricular mapping will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the ratio of mean pulmonary artery pressure and cardiac output (mPAP/CO) between rest and the exercise tests in a patient
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Within each patient, the ratio of resting mean pulmonary artery pressure and cardiac output (mPAP/CO) will be compared to each exercise mode (isometric handgrip testing vs. dynamic resistance testing vs. 20minutes endurance exercise vs. 40 minutes endurance exercise) in a patient
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the pulmonary pulsatility index (PAPi) between rest and the exercise tests in a patient
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Within each patient, resting pulmonary pulsatility index (PAPi) will be compared to each exercise mode (isometric handgrip testing vs. dynamic resistance testing vs. 20minutes endurance exercise vs. 40 minutes endurance exercise) in a patient
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Difference of the ratio of right atrial pressure to pulmonary artery wedge pressure (RA/PAWP) between rest and the exercise tests in a patient
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Within each patient, the ratio of resting right atrial pressure to pulmonary artery wedge pressure (RAP/PAWP) will be compared to each exercise mode (isometric handgrip testing vs. dynamic resistance testing vs. 20minutes endurance exercise vs. 40 minutes endurance exercise) in a patient
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Difference of right ventricular power output reserve (RVPO reserve) between rest and exercise tests in a patient
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Right ventricular power output (RVPO) reserve (calculated as the difference between resting and exercise power output of the right ventricle (power output is calculated at rest and at the end of each condition as mean pulmonary artery pressure × cardiac output/451. Differences are compared within a patient between the exercise modes. Exercise modes are the following: Isometric handgrip testing vs. dynamic resistance testing vs. 20minutes endurance exercise vs. 40 minutes endurance exercise.
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Change in voltage maps during resting and the different exercise modes per patient
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Voltage maps are compared in each patient between the resting measurement before exercise and after completion of all exercise modes (isometric handgrip testing, dynamic resistance testing, 20minutes endurance exercise, 40 minutes endurance exercise.)
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Between group differences of the changes in the ratio of mean pulmonary artery pressure and cardiac output (mPAP/CO) between rest and the exercise tests
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Changes in the ratio of mean pulmonary artery pressure and cardiac output (mPAP/CO) between rest and the exercise modes will be compared between the two groups (patients with an implantable cardioverter defibrillator vs. those without). The exercise modes are the following: Isometric handgrip testing, dynamic resistance testing, 20minutes endurance exercise, 40 minutes endurance exercise.
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Between group differences of the changes in voltage maps of the right ventricle between rest and the exercise tests.
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Changes in the voltage maps of the right ventricle (rest compared to the exercise modes) will be compared between the two groups (patients with an implantable cardioverter defibrillator vs. those without). The exercise modes are the following: Isometric handgrip testing, dynamic resistance testing, 20minutes endurance exercise, 40 minutes endurance exercise.
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Between group difference of cardiac biomarkers etween rest and the exercise tests.
Time Frame: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Changes in the cardiac biomarkers troponin I and N-terminal pro-B-type natriuretic peptide (rest compared to the exercise modes) will be compared between the two groups (patients with an implantable cardioverter defibrillator vs. those without). The exercise modes are the following: Isometric handgrip testing, dynamic resistance testing, 20minutes endurance exercise, 40 minutes endurance exercise.
Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)

Collaborators and Investigators

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

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Simon Wernhart, MD, Technical University Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2025

Primary Completion (Actual)

March 12, 2026

Study Completion (Actual)

March 15, 2026

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-563-S-NP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will only be shared anonymously on reasonable request to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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