Fontan Patients: Comprehensive Evaluation of Pulmonary Circulation and Ventricular Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexander Van De Bruaene, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01572363
First received: April 3, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Congenital Heart Disease
Drug: Sildenafil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Fontan Patients: Comprehensive Evaluation of the Pulmonary Circulation to Identify Pulmonary Vascular Disease and Its Influence on Ventricular Hemodynamics.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Systemic ventricular stroke volume during exercise [ Time Frame: 30 minutes after administration of sildenafil ] [ Designated as safety issue: No ]
    Systemic ventricular stroke volume during exercise as evaluated using bicycle stress magnetic resonance imaging.


Enrollment: 10
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sildenafil
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
50 mg once
Other Names:
  • Sildenafil
  • Viagra
  • Revatio

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to performe exercise
  • Contra-indication for MR evaluation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572363

Locations
Belgium
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Werner Budts, MD, PhD University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Alexander Van De Bruaene, Dr, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01572363     History of Changes
Other Study ID Numbers: ML6721
Study First Received: April 3, 2012
Last Updated: March 4, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
Fontan
Cardiac magnetic resonance imaging
Sildenafil

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 27, 2014