Right ventricle remodeling after pulmonary valve replacement and percutaneous pulmonary valve insertion, a functional and histopathological assessment.

Right ventricle remodeling after pulmonary valve replacement and percutaneous pulmonary valve insertion, a functional and histopathological assessment. - RV-REPAIR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43787

Enrollment

Registered

2015-10-21

Start date

2016-02-08

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease pulmonary valve dysfunction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Grown-up congenital heart disease patients with pulmonary insufficiency and/or stenosis and an indication for pulmonary valve replacement or percutaneous pulmonary valve insertion according to local GUCH team advise (based on current ESC GUCH guidelines). Also subjects who do not meet the indication criteria for valve replacement are eligible to participate in the study. They will form a conservative cohort.

Exclusion criteria

Exclusion criteria: - Individual is younger than 18 years of age. - Individual has an estimated glomerular filtration rate (eGFR) of

Design outcomes

Primary

Measure	Time frame
Cardiac magnetic resonance parameters including T1, T1 rho relaxation time and LGE (late gadolinium enhancement) for fibrosis. Histopathologiy: percentage of of fibrosis.	—

Secondary

Measure	Time frame
Echocardiograpic parameters including strain and strainrate. Cardiopulmonary excercise testing. Electrocardiograpy and Holter testing. Laboratory tests (BNP, ANP, hs-troponine, hs-CRP, cystatine C, PICP, TIMP-1). Quality of life questionnaires (SF-36 and TAAQOL).	—

Countries

Netherlands

Outcome results