Arrhythmias, CardiacNCT06823271
Haemodynamics and Ventricular Arrhythmias During Exercise in Patients With Arrhythmogenic Cardiomyopathy
A study testing Resting and exercise right heart catheterization and Right ventricular mapping in people with Arrhythmias, Cardiac, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Resting and exercise right heart catheterization and Right ventricular mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years of age
- Diagnosis of definitive or borderline arrhythmogenic cardiomyopathy (ACM) with or without implantable cardioverter defibrillator (ICD)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Resting and exercise right heart catheterization, Right ventricular mapping
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting and exercise right heart catheterizationOther
At rest and after different modes of exercise, exercise right heart catheterization will be performed.
Right ventricular mappingOther
At the beginning and at the end of the exercise modes right ventricular mapping will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 with implantable cardioverter-defibrillator | Other | Patients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy and implantable cardioverter-defibrillator will be included. Receives: 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. Receives: Other: Resting and exercise right heart catheterization; Other: Right ventricular mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Change in voltage maps during resting and the different exercise modes per patient
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.)
Measured: 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
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.
Measured: 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.
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.
Measured: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Between group difference of cardiac biomarkers etween rest and the exercise tests.
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.
Measured: Through study completion, 48 hours after cardiopulmonary exercise testing (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Aug 2025
- Primary completion12 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Wernhart, MD, Principal investigator, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823271
- Sponsor's protocol ID
- 2024-563-S-NP
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will only be shared anonymously on reasonable request to the principal investigator.
Publications
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.
PubMed 37565370Gasperetti 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.
PubMed 32976989Sawant 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.
PubMed 26321091Marcus 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.
PubMed 20172912Corrado 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.
PubMed 37844667Cadrin-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.
PubMed 36263795Corrado 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.
PubMed 26216920Saberniak 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.
PubMed 25319773
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamics and Ventricular Arrhythmias During Moderate-intensity Endurance and Resistance Exercise in Patients With Arrhythmogenic Cardiomyopathy, a Pilot Study
- ClinicalTrials.gov ID
- NCT06823271
- Acronym / sponsor ID
- 2024-563-S-NP
- Conditions
- Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 with implantable cardioverter-defibrillator | Other | Other: Resting and exercise right heart catheterization, Other: Right ventricular mappingPatients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy and implantable cardioverter-defibrillator will be included. |
| Group 2 without implantable cardioverter-defibrillator | Other | Other: Resting and exercise right heart catheterization, Other: Right ventricular mappingPatients with diagnosed definitive or borderline arrhythmogenic cardiomyopathy without implantable cardioverter-defibrillator will be included. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years of age
- Diagnosis of definitive or borderline arrhythmogenic cardiomyopathy (ACM) with or without implantable cardioverter defibrillator (ICD)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting and exercise right heart catheterizationAt rest and after different modes of exercise, exercise right heart catheterization will be performed. | Other | Group 1 with implantable cardioverter-defibrillator, Group 2 without implantable cardioverter-defibrillator |
| Right ventricular mappingAt the beginning and at the end of the exercise modes right ventricular mapping will be performed. | Other | Group 1 with implantable cardioverter-defibrillator, Group 2 without implantable cardioverter-defibrillator |
Primary outcome
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
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 37565370Wernhart 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.
- Results publication: PubMed 32976989Gasperetti 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.
- Results publication: PubMed 26321091Sawant 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.
- Results publication: PubMed 20172912Marcus 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.
- Results publication: PubMed 37844667Corrado 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.
- Results publication: PubMed 36263795Cadrin-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.
- Results publication: PubMed 26216920Corrado 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.
- Results publication: PubMed 25319773Saberniak 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.
- Individual participant dataSharing planned: No. Individual data will only be shared anonymously on reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Wernhart, MD principal investigator
Technical University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resting and exercise right heart catheterization and Right ventricular mapping in people with Arrhythmias, Cardiac, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823271, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.