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

Primary Purpose

Congenital Heart Disease With Systemic Right Ventricle

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

asymptomatic group

symptomatic group

About this trial

This is an interventional diagnostic trial for Congenital Heart Disease With Systemic Right Ventricle focused on measuring systemic right ventricle, cardiac magnetic resonance imaging, congenital heart disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hôpital Européen Georges Pompidou

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Arm Label

asymptomatic group

symptomatic group

control

Arm Description

patients with systemic right ventricle who are asymptomatic,

symptomatic group : patients with systemic right ventricle and heart failure signs and/or decrease exercise performance

healthy subject matched with patients of asymptomatic group

Outcomes

Primary Outcome Measures

remodelling indexes

wall stress index

fibrosis of systemic RV measured by MRI

Secondary Outcome Measures

echographic measures of RV function and geometry indexes

comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow

Arterial mechanical properties (stiffness aortic distensibility and arterial compliance)

comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow

Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides

Variability and reproducibility indices remodeling and wall stress MRI

inter and intra-observer variability and inter-examination MRI measures

Full Information

NCT ID

NCT02066506

First Posted

September 17, 2013

Last Updated

March 31, 2015

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02066506

Brief Title

Study of Adaptation of the Right Ventricle to Systemic Afterload

Acronym

STARS

Official Title

Study of Adaptation of the Right Ventricle to Systemic Afterload

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Disease With Systemic Right Ventricle

Keywords

systemic right ventricle, cardiac magnetic resonance imaging, congenital heart disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

asymptomatic group

Arm Type

Sham Comparator

Arm Description

patients with systemic right ventricle who are asymptomatic,

Arm Title

symptomatic group

Arm Type

Sham Comparator

Arm Description

symptomatic group : patients with systemic right ventricle and heart failure signs and/or decrease exercise performance

Arm Title

control

Arm Type

Sham Comparator

Arm Description

healthy subject matched with patients of asymptomatic group

Intervention Type

Other

Intervention Name(s)

asymptomatic group

Intervention Description

2 visits with MRI

Intervention Type

Other

Intervention Name(s)

symptomatic group

Intervention Description

2 visits with MRI

Primary Outcome Measure Information:

Title

remodelling indexes

Time Frame

48 months

Title

wall stress index

Time Frame

48 months

Title

fibrosis of systemic RV measured by MRI

Time Frame

48 months

Secondary Outcome Measure Information:

Title

echographic measures of RV function and geometry indexes

Description

comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow

Time Frame

48 months

Title

Arterial mechanical properties (stiffness aortic distensibility and arterial compliance)

Description

comparison between patients and healthy subjects and analysis of the evolution of the measured parameters in the 2 groups after one year of follow

Time Frame

48 months

Title

Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides

Time Frame

48 months

Title

Variability and reproducibility indices remodeling and wall stress MRI

Description

inter and intra-observer variability and inter-examination MRI measures

Time Frame

48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magalie Ladouceur, MD

Organizational Affiliation

Université Paris Descartes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Européen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Learn more about this trial

Study of Adaptation of the Right Ventricle to Systemic Afterload

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