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Study of Adaptation of the Right Ventricle to Systemic Afterload (STARS)

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ClinicalTrials.gov Identifier: NCT02066506
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
the first purpose of the study is to determine the adaptative mechanisms of right ventricle (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels

Condition or disease Intervention/treatment Phase
Congenital Heart Disease With Systemic Right Ventricle Other: asymptomatic group Other: symptomatic group Not Applicable

Detailed Description:
Right ventricle (RV) in sub-aortic position is a rare situation, mainly in two congenital heart defects: congenitally corrected transposition of the great arteries and complete transposition of the great arteries palliated by atrial switch. In these patients, increase of afterload leads to hypertrophy and late RV dilatation. The stress exercised on RV walls could play a role in adaptative mechanisms to systemic afterload. Beyond a remodelling threshold, it could cause fibrosis damage and RV systolic failure. Magnetic resonance imaging, which has a major potential in estimation of RV remodelling, wall stress and fibrosis, could shed light on RV adaptation to systemic afterload and evolution towards failure. Systemic RV remodelling and function could also depend on the neuro-hormone secretion and mechanical arterial properties, that have a direct influence on patients afterload. The first purpose of the study is to determine the adaptative mechanisms of RV to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Adaptation of the Right Ventricle to Systemic Afterload
Study Start Date : February 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Sham Comparator: asymptomatic group
patients with systemic right ventricle who are asymptomatic,
Other: asymptomatic group
2 visits with MRI

Sham Comparator: symptomatic group
symptomatic group : patients with systemic right ventricle and heart failure signs and/or decrease exercise performance
Other: symptomatic group
2 visits with MRI

Sham Comparator: control
healthy subject matched with patients of asymptomatic group
Other: asymptomatic group
2 visits with MRI

Other: symptomatic group
2 visits with MRI




Primary Outcome Measures :
  1. remodelling indexes [ Time Frame: 48 months ]
  2. wall stress index [ Time Frame: 48 months ]
  3. fibrosis of systemic RV measured by MRI [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. echographic measures of RV function and geometry indexes [ Time Frame: 48 months ]
    comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow

  2. Arterial mechanical properties (stiffness aortic distensibility and arterial compliance) [ Time Frame: 48 months ]
    comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow

  3. Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides [ Time Frame: 48 months ]
  4. Variability and reproducibility indices remodeling and wall stress MRI [ Time Frame: 48 months ]
    inter and intra-observer variability and inter-examination MRI measures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patients inclusion criteria:

  • patients with a systemic right ventricle
  • to have an insurance
  • to obtain informed consent

Patients non-inclusion criteria:

  • patients with cyanosis defined by a saturation ≤ 85% at rest
  • patients with a ventricular septal defect non repaired at the time of inclusion
  • contraindications normal MRI
  • contraindication to achieving a stress test
  • Glomerular Filtration Rate inf 30ml/mn/1.73m²
  • physical or mental disability that does not allow to perform a cardiopulmonary exercise test
  • patients with already severe allergy to gadolinium MRI contrast
  • current Pregnancy
  • patients who can not be monitored over the period of one year, patient participating in another research on the Treatment interacting with the neurohormonal system in particular the renin-angiotensin-aldosterone system

healthy subjects inclusion criteria:

  • matched for age and sex + / - 5 years of an asymptomatic patient
  • Normal ECG
  • normal Echocardiography
  • clinical examination prior
  • Patient receiving an insurance
  • Obtaining informed consent

healthy subjects Exclusion criteria:

  • History of myocardial infarction-known or detectable on the ECG-abnormal Liver function tests
  • Complete Blood Count
  • electrolytes
  • viral serology
  • Primary or secondary cardiomyopathy-known or detectable on echocardiography
  • History of thoracic radiotherapy or chemotherapy
  • Contraindications MRI
  • Counter-indication for performing a stress test
  • Patient with severe renal clearance less than Glomerular Filtration Rate inf 30ml/mn/1.73m²
  • Patient has already made a severe allergy to gadolinium MRI contrast Current Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066506


Locations
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France
Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Magalie Ladouceur, MD Université Paris Descartes
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02066506    
Other Study ID Numbers: P080609
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: August 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
systemic right ventricle
cardiac magnetic resonance imaging
congenital heart disease
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases