Haemodynamics and Ventricular Arrhythmias During Exercise in Patients With Arrhythmogenic Cardiomyopathy

NCT06823271 | Completed

• 1 other identifier: 2024-563-S-NP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• Difference of the ratio of mean pulmonary artery pressure and cardiac output (mPAP/CO) between rest and the exercise tests in a patient

  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 Outcomes (7)

• Difference of the pulmonary pulsatility index (PAPi) between rest and the exercise tests 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

  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

  Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)

• Change in voltage maps during resting and the different exercise modes per patient

  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

  Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)

Study Arms (2)

Group 1 with implantable cardioverter-defibrillator

OTHER

Patients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy and implantable cardioverter-defibrillator will be included.

Other: Resting and exercise right heart catheterization; Other: Right ventricular mapping

Group 2 without implantable cardioverter-defibrillator

OTHER

Patients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy without implantable cardioverter-defibrillator will be included.

Other: Resting and exercise right heart catheterization; Other: Right ventricular mapping

Interventions

Resting and exercise right heart catheterization OTHER

At rest and after different modes of exercise, exercise right heart catheterization will be performed.

Group 1 with implantable cardioverter-defibrillator; Group 2 without implantable cardioverter-defibrillator

Right ventricular mapping OTHER

At the beginning and at the end of the exercise modes right ventricular mapping will be performed.

Group 1 with implantable cardioverter-defibrillator; Group 2 without implantable cardioverter-defibrillator

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Technische Universität München

München, 81675, Germany

Location

Related Publications (8)

• Wernhart S, Goertz A, Hedderich J, Papathanasiou M, Hoffmann J, Rassaf T, Luedike P. Diastolic exercise stress testing in heart failure with preserved ejection fraction: The DEST-HF study. Eur J Heart Fail. 2023 Oct;25(10):1768-1780. doi: 10.1002/ejhf.2995. Epub 2023 Aug 24.

  PMID: 37565370 RESULT

• Gasperetti A, Rossi VA, Chiodini A, Casella M, Costa S, Akdis D, Buchel R, Deliniere A, Pruvot E, Gruner C, Carbucicchio C, Manka R, Dello Russo A, Tondo C, Brunckhorst C, Tanner F, Duru F, Saguner AM. Differentiating hereditary arrhythmogenic right ventricular cardiomyopathy from cardiac sarcoidosis fulfilling 2010 ARVC Task Force Criteria. Heart Rhythm. 2021 Feb;18(2):231-238. doi: 10.1016/j.hrthm.2020.09.015. Epub 2020 Sep 22.

  PMID: 32976989 RESULT

• Sawant AC, Te Riele AS, Tichnell C, Murray B, Bhonsale A, Tandri H, Judge DP, Calkins H, James CA. Safety of American Heart Association-recommended minimum exercise for desmosomal mutation carriers. Heart Rhythm. 2016 Jan;13(1):199-207. doi: 10.1016/j.hrthm.2015.08.035. Epub 2015 Aug 29.

  PMID: 26321091 RESULT

• Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the Task Force Criteria. Eur Heart J. 2010 Apr;31(7):806-14. doi: 10.1093/eurheartj/ehq025. Epub 2010 Feb 19.

  PMID: 20172912 RESULT

• Corrado D, Anastasakis A, Basso C, Bauce B, Blomstrom-Lundqvist C, Bucciarelli-Ducci C, Cipriani A, De Asmundis C, Gandjbakhch E, Jimenez-Jaimez J, Kharlap M, McKenna WJ, Monserrat L, Moon J, Pantazis A, Pelliccia A, Perazzolo Marra M, Pillichou K, Schulz-Menger J, Jurcut R, Seferovic P, Sharma S, Tfelt-Hansen J, Thiene G, Wichter T, Wilde A, Zorzi A. Proposed diagnostic criteria for arrhythmogenic cardiomyopathy: European Task Force consensus report. Int J Cardiol. 2024 Jan 15;395:131447. doi: 10.1016/j.ijcard.2023.131447. Epub 2023 Oct 14.

  PMID: 37844667 RESULT

• Cadrin-Tourigny J, Bosman LP, James CA. Sudden cardiac death risk prediction in arrhythmogenic right ventricular cardiomyopathy: a practical approach to navigating the challenges of prediction models. Eur Heart J. 2022 Dec 14;43(47):4961-4962. doi: 10.1093/eurheartj/ehac562. No abstract available.

  PMID: 36263795 RESULT

• Corrado D, Wichter T, Link MS, Hauer R, Marchlinski F, Anastasakis A, Bauce B, Basso C, Brunckhorst C, Tsatsopoulou A, Tandri H, Paul M, Schmied C, Pelliccia A, Duru F, Protonotarios N, Estes NA 3rd, McKenna WJ, Thiene G, Marcus FI, Calkins H. Treatment of arrhythmogenic right ventricular cardiomyopathy/dysplasia: an international task force consensus statement. Eur Heart J. 2015 Dec 7;36(46):3227-37. doi: 10.1093/eurheartj/ehv162. Epub 2015 Jul 27. No abstract available.

  PMID: 26216920 RESULT

• Saberniak J, Hasselberg NE, Borgquist R, Platonov PG, Sarvari SI, Smith HJ, Ribe M, Holst AG, Edvardsen T, Haugaa KH. Vigorous physical activity impairs myocardial function in patients with arrhythmogenic right ventricular cardiomyopathy and in mutation positive family members. Eur J Heart Fail. 2014 Dec;16(12):1337-44. doi: 10.1002/ejhf.181. Epub 2014 Oct 16.

  PMID: 25319773 RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Wernhart, MD

  Technical University Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this interventional study patients will be separated into 2 groups with 10 patients per group Group 1: Patients with an implantable cardioverter-defibrillator Group 2: Patients without an implantable cardioverter-defibrillator

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 12, 2025
• Study Start: August 1, 2025
• Primary Completion: March 12, 2026
• Study Completion: March 15, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)