Right Ventricle Remodeling After Pulmonary Valve Replacement and Percutaneous Pulmonary Valve Insertion

NCT05090228 | Completed DMC

• 2 other identifiers: NL53771.041.1515-448/M
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates damage of the right cardiac chamber in adult patients with a congenital heart defect involving the pulmonary valve (the heart valve between the right cardiac chamber and the lungs). The investigators want to investigate if novel, less invasive techniques are feasible to assess damage of this right cardiac chamber, to improve follow-up and timing of intervention (valve replacement) in this group of patients.

Conditions

Endomyocardial Fibrosis; Pulmonary Valve Stenosis; Pulmonary Valve Insufficiency

Keywords

Right ventricle (reverse) remodeling (fibrosis); Right ventricle pressure overloading; Right ventricle volume overloading

Outcome Measures

Primary Outcomes (4)

• histopathology: percentage of fibrosis in biopsies.

  endomyocardial biopsies performed during valve replacement RV endomyocardial biopsies performed during valve replacement procedure.

  6 months

• T1 time in ms

  CMR

  before and 6 months after valve replacement

• T1 rho time in ms

  CMR

  before and 6 months after valve replacement

• Late gadolinium enhancement

  CMR

  before and 6 months after valve replacement

Secondary Outcomes (4)

• Echocardiographic parameters

  before valve replacement and direct post-intervention, 1month and 6 months post-intervention

• Electrocardiographic sign of RV hypertrophy

  before and 6 months after valve replacement (ECG and Holter)

• Biomarkers

  Before and 6 months after valve replacement

• Quality of life SF-36

  before and 6 months after valve replacement

Study Arms (1)

PVR/PPVI

Adult patients with congenital heart disease (GUCH) undergoing pulmonary valve replacement (PVR) or percutaneous pulmonary valve insertion (PPVI).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with congenital heart disease with severe Pulmonary Insufficiency and/or Pulmonary Stenosis with an indication for PVR or PPVI.

You may qualify if:

• Individual should meet the European Society of Cardiology criteria for pulmonary valve intervention according to congenital heart disease guidelines.
• Individual has an indication for PVR or PPVI according to the local GUCH heart team
• Individual is ≥18 years of age.
• Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.
• Patients are acceptable candidates for PVR or PPVI treatment in accordance with manufacturer's instructions for use.

You may not qualify if:

• Individual is younger than 18 years of age.
• Individual has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD (Modification of Diet in Renal Disease) calculation.
• Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia).
• Individual is pregnant, nursing or planning to be pregnant.
• Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
• Individual is currently enrolled in an investigational drug or device trial.
• Individual with any contraindications for MRI:
• The presence of implanted non-MRI-compatible cardiac pacemaker or implanted cardioverter defibrillator.
• Implanted electronic devices like cochlear implants and nerve stimulators.
• Patients who are unable to fit into the bore of the magnet.
• Claustrophobia

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for biomarker studies. Endomyocardial biopsies for (diffuse) fibrosis studies.

MeSH Terms

Conditions

Endomyocardial Fibrosis; Pulmonary Valve Stenosis; Pulmonary Valve Insufficiency; Fibrosis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michiel Voskuil, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. Voskuil, MD, PhD

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: October 22, 2021
• Study Start: February 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

NL (1)