Haemodynamics and Ventricular Arrhythmias During Exercise in Patients With Arrhythmogenic Cardiomyopathy
NCT ID: NCT06823271
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-08-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group 1 with implantable cardioverter-defibrillator
Patients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy and implantable cardioverter-defibrillator will be included.
Resting and exercise right heart catheterization
At rest and after different modes of exercise, exercise right heart catheterization will be performed.
Right ventricular mapping
At the beginning and at the end of the exercise modes right ventricular mapping will be performed.
Group 2 without implantable cardioverter-defibrillator
Patients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy without implantable cardioverter-defibrillator will be included.
Resting and exercise right heart catheterization
At rest and after different modes of exercise, exercise right heart catheterization will be performed.
Right ventricular mapping
At the beginning and at the end of the exercise modes right ventricular mapping will be performed.
Interventions
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Resting and exercise right heart catheterization
At rest and after different modes of exercise, exercise right heart catheterization will be performed.
Right ventricular mapping
At the beginning and at the end of the exercise modes right ventricular mapping will be performed.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of definitive or borderline arrhythmogenic cardiomyopathy (ACM) with or without implantable cardioverter defibrillator (ICD)
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Simon Wernhart, MD
Role: PRINCIPAL_INVESTIGATOR
Technical University Munich
Locations
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Technische Universität München
München, , Germany
Countries
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Central Contacts
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Facility Contacts
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Simon Wernhart, MD
Role: primary
Martin Halle, MD
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2024-563-S-NP
Identifier Type: -
Identifier Source: org_study_id