Status:
UNKNOWN
Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease
Lead Sponsor:
Heart Center Leipzig - University Hospital
Conditions:
Pulmonary Regurgitation
Congenital Heart Disease
Eligibility:
All Genders
12-80 years
Phase:
NA
Brief Summary
The aim of the study is to assess the characteristics, incidence and predictors of load-independent right ventricle (RV) diastolic dysfunction in patients with congenital heart disease (CHD) and adver...
Detailed Description
One of the major problems in the expanding population of patients with congenital heart disease (CHD) is dysfunction of the right ventricular (RV) outflow tract (OT). Initial surgical repair for compl...
Eligibility Criteria
Inclusion
- Patient with CHD involving the RV
- Chronic RV volume and/or pressure overload as defined by:
- more than mild pulmonary regurgitation and/or
- more than mild tricuspid regurgitation and/or
- a gradient across the RV outflow tract of ≥ 3 m/s on echocardiography and/or
- estimated RV systolic pressure \> 65 mmHg
- Clinical indication for cardiac catheterization
- Age 12 to 80 years
- Informed consent
Exclusion
- Contraindication for magnetic resonance imaging or cardiopulmonary exercise testing
- Pregnancy
- RV systolic function on magnetic resonance imaging \< 45%
Key Trial Info
Start Date :
July 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03471936
Start Date
July 7 2016
End Date
August 1 2022
Last Update
May 10 2021
Active Locations (1)
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1
Heart Center of the University Leipzig
Leipzig, Germany, 04289