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

NCT02648984 | Completed

• 1 other identifier: S56272
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Vascular Disease

Keywords

Pulmonary vascular disease

Outcome Measures

Primary Outcomes (1)

• Pulmonary artery pressure - flow plot

  Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting

Secondary Outcomes (1)

• Maximal Oxygen Uptake

  Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting

Study Arms (2)

Patient group

OTHER

Patients with ventricular septal defect

Other: The intervention is performing an exercise test

Control group

OTHER

Healthy control subjects

Other: The intervention is performing an exercise test

Interventions

The intervention is performing an exercise test OTHER

Patients and controls will undergo a bicycle stress echocardiography and a cardiopulmonary exercise test

Control group; Patient group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other congenital heart disease
• PAH of any aetiology other than VSD
• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Study Officials

• Werner Budts, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Werner Budts, MD, PhD

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 7, 2016
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

BE (1)