Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With Closed Ventricular Septal Defect

May 2, 2017 updated by: prof. dr. Werner Budts, Universitaire Ziekenhuizen KU Leuven

Ad Hoc Analysis for the Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With a Closed Ventricular Septal Defect

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to increased pulmonary vascular resistance (PVR), leading to right ventricular dysfunction, considerable morbidity and even mortality.

Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease already evolved to an advanced stage and treatment is often initiated too late. Our research group standardized the technique for the detection of early pulmonary vascular disease by bicycle stress echocardiography. The investigators now aim to assess this exercise technique in a group of patients with ventricular septal defect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to increased pulmonary vascular resistance (PVR). PAH may lead to right ventricular and right atrial dysfunction, which may implicate considerable morbidity and even mortality.

Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease already evolved to an advanced stage and treatment is often initiated too late. Our research group standardized the technique for the detection of early pulmonary vascular disease by bicycle stress echocardiography. Exercise-induced pulmonary hypertension has been recognised as a clinical entity, but is not included in the current guidelines on pulmonary hypertension. Further research in this area might imply the need for revision of the current PAH detection and treatment strategy.

By performing stress echocardiography and cardiopulmonary exercise testing, the investigators want to reach the following objectives:

  • To answer the question whether the abnormal increase in PAP during exercise, seen in patients with late atrial septal defect (ASD) type secundum closure, is also present in congenital heart disease (CHD) patients who were treated for other shunt lesions.
  • To apply this early detection technique in a broader population of CHD patients and to better define the predictive value of an elevated PVR during exercise.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects with ventricular septal defect (VSD) repair at least 6 months before study enrolment
  • No discrimination in type of VSD repair will be made (percutaneous or surgical)
  • Subjects must be able to perform exercise testing

Exclusion Criteria:

  • Other congenital heart disease
  • PAH of any aetiology other than VSD
  • Inclusion in other treatment protocols
  • Impairment of organic function (renal, hepatic)
  • Arterial hypotension (systolic blood pressure < 85 mmHg)
  • Anaemia (Hb < 10 g/dl)
  • Thrombocytopenia (< 50000/µl)
  • Significant valvular disease, other than tricuspid or pulmonary regurgitation
  • Chronic lung disease or total lung capacity < 80% of predicted value
  • History of pulmonary embolism
  • Cyanotic patients, patients in an unstable condition and patients who have to undergo re-intervention during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient group
Patients with ventricular septal defect
Other: The intervention is performing an exercise test
Patients and controls will undergo a bicycle stress echocardiography and a cardiopulmonary exercise test
Other: Control group
Healthy control subjects
Other: The intervention is performing an exercise test
Patients and controls will undergo a bicycle stress echocardiography and a cardiopulmonary exercise test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary artery pressure - flow plot
Time Frame: Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting
Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal Oxygen Uptake
Time Frame: Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting
Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Werner Budts, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Vascular Disease

Clinical Trials on The intervention is performing an exercise test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe