Fontan Patients: Comprehensive Evaluation of Pulmonary Circulation and Ventricular Function

NCT01572363 | Completed

• 1 other identifier: ML6721
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with one anatomical or functional ventricular chamber, which encompasses a spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in view of an ultimate Fontan operation has become the procedure of choice. Especially in the earlier era, perioperative mortality was the leading cause of death. However, many patients have a long and high-quality life, continuously improved by a better understanding of Fontan hemodynamics and the refinement of the surgical procedures. Nevertheless, the prospect of eventual failure of the Fontan circulation remains a major concern. More specifically, evaluation of the pulmonary circulation becomes particularly important as the failing Fontan circulation has become a common indication for cardiac transplantation. Although essential, especially in the preoperative setting, a comprehensive evaluation of the pulmonary circulation remains difficult in this patient population Our global hypothesis is that the absence of pulsatile pulmonary flow may lead to the development of pulmonary vascular lesions after the Fontan operation and that - together the absence of a subpulmonary ventricle for pressure generation - this increasing afterload will result in systemic ventricular underfilling and will eventually lead to a failing Fontan circulation.

Conditions

Congenital Heart Disease

Keywords

Fontan; Cardiac magnetic resonance imaging; Sildenafil

Outcome Measures

Primary Outcomes (1)

• Systemic ventricular stroke volume during exercise

  Systemic ventricular stroke volume during exercise as evaluated using bicycle stress magnetic resonance imaging.

  30 minutes after administration of sildenafil

Study Arms (1)

Sildenafil

EXPERIMENTAL

All patients will be given Sildenafil 50 mg with evaluation of pulmonary vascular resistance and systemic ventricular function at rest and during exercise after 30 minutes.

Drug: Sildenafil

Interventions

Sildenafil DRUG

50 mg once

Also known as: Viagra, Revatio

Sildenafil

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 14 years of age
• Written informed consent
• Fontan pathology

You may not qualify if:

• Inability to performe exercise
• Contra-indication for MR evaluation

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Werner Budts, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 6, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

BE (1)