Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

NCT01815502 | Completed Phase 4 Results

• 2 other identifiers: PVL FontanAHA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the cardiovascular effects of sildenafil on patients with Fontan circulation. Recent studies suggest that sildenafil may improve exercise in patients with Fontan circulation. However, why this occurs is not known. The study will used specialized catheters to measure pressure and volume. The measure of pressure and volume leads to more detailed analysis of heart function. Patients will receive either sugar pill or sildenafil prior to catheterization. It is believed that sildenafil will improve relaxation and contraction of the heart.

Conditions

Single Ventricle Heart Disease After Fontan Surgery

Keywords

Single ventricle; Fontan; Sildenafil; Pressure-Volume Loops

Outcome Measures

Primary Outcomes (1)

• End-systolic Elastance

  end-systolic elastance (often abbreviated Ees or ESPVR) is a measure of contractility (systolic function)

  10 minutes after imitation of dobutamine

Secondary Outcomes (1)

• End-diastolic Pressure Volume Relationship

  10 minutes after imitation of dobutamine

Other Outcomes (2)

• Ventricular-arterial Coupling

  10 minutes after imitation of dobutamine

• Preload Augmentation

  10 minutes after imitation of dobutamine

Study Arms (2)

Dobutamine + Sildenafil

EXPERIMENTAL

Sildenafil will be given an one time dose 30 to 90 minutes prior to cardiac catheterization. Sildenafil will be given at a dose 1 milligram per kilogram with a maximum of 20 milligrams. During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Diagnostic Test: Cardiac catheterization

Dobutamine + placebo

PLACEBO COMPARATOR

Patients will be given a one time dose of sugar pill 30 to 90 minutes prior to cardiac catheterization.During the catheterization patients will have specialized catheter placed in the heart that measures pressure and volume simultaneously. The patients will undergo an infusion of dobutamine up to 10 micrograms per kilogram per minute to mimic exercise for up to ten minutes..

Diagnostic Test: Cardiac catheterization

Interventions

Cardiac catheterization DIAGNOSTIC_TEST

All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.

Dobutamine + Sildenafil; Dobutamine + placebo

Eligibility Criteria

• Age: 3 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presence of a congenital heart defect that leads to single ventricle physiology
• Previously performed Fontan surgery

You may not qualify if:

• The use of phosphodiesterase type 5 (PDE5) inhibitors at the time of catheterization of within 1 month of catheterization
• Unstable arrhythmia at the time of catheterization
• History of unstable arrhythmia within 2 months of catheterization
• Venous, arterial or cardiac malformation that precludes the proper placement of a microconductance catheter
• Allergy to sildenafil or previous significant adverse reaction to sildenafil (e.g. hypotension)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• American Heart Association: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

• Goldberg DJ, French B, McBride MG, Marino BS, Mirarchi N, Hanna BD, Wernovsky G, Paridon SM, Rychik J. Impact of oral sildenafil on exercise performance in children and young adults after the fontan operation: a randomized, double-blind, placebo-controlled, crossover trial. Circulation. 2011 Mar 22;123(11):1185-93. doi: 10.1161/CIRCULATIONAHA.110.981746. Epub 2011 Mar 7.

  PMID: 21382896 BACKGROUND

• Goldberg DJ, French B, Szwast AL, McBride MG, Marino BS, Mirarchi N, Hanna BD, Wernovsky G, Paridon SM, Rychik J. Impact of sildenafil on echocardiographic indices of myocardial performance after the Fontan operation. Pediatr Cardiol. 2012 Jun;33(5):689-96. doi: 10.1007/s00246-012-0196-9. Epub 2012 Feb 14.

  PMID: 22331056 BACKGROUND

• Butts RJ, Chowdhury SM, Baker GH, Bandisode V, Savage AJ, Atz AM. Effect of Sildenafil on Pressure-Volume Loop Measures of Ventricular Function in Fontan Patients. Pediatr Cardiol. 2016 Jan;37(1):184-91. doi: 10.1007/s00246-015-1262-x. Epub 2015 Sep 26.

  PMID: 26409473 DERIVED

MeSH Terms

Conditions

Univentricular Heart

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Dr. Andrew M Atz
• Organization: MUSC

atzam@musc.edu

843-876-1698

Study Officials

• Ryan Butts, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Andrew M Atz, MD

  Medical University of South Carolina

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-11

Locations

US (1)