Effects of Pulmonary Vasodilation Upon VA Coupling in Fontan Patients

NCT01607983 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 11-06070
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves documenting the effects of inhaled nitric oxide upon ventricular-arterial coupling in patients with congenital heart disease and passive pulmonary blood flow. Consenting patients undergoing a clinically-indicated cardiac catheterization will be given inhaled nitric oxide for 10 minutes while intraventricular pressure-volume analysis will be make via conduction catheters.

Conditions

Congenital Heart Disease; Fontan

Keywords

nitric oxide; ventricular-arterial coupling; congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Effective arterial elastance (Ea)

  Patients will undergo hemodynamic evaluation while receiving inhaled nitric oxide. After the measurements are made the nitric oxide will be discontinued. The primary outcome is the change in effective arterial elastance, a value obtained from ventricular pressure-volume assessment, before and while receiving nitric oxide.

  Acute, approximately 10-15 minutes

Study Arms (1)

inhaled nitric oxide

EXPERIMENTAL

Drug: inhaled nitric oxide

Interventions

inhaled nitric oxide DRUG

20 parts per million (ppm) of inhaled nitric oxide

inhaled nitric oxide

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All consecutive patients with single ventricle hearts having passive pulmonary blood flow presenting to the cardiac catheterization laboratory for clinically indicated cardiac catheterization.

You may not qualify if:

• Patients with coarctation of the aorta or known bilateral femoral arterial obstruction
• Patients with known severe systemic venous/Fontan obstruction
• Patients already receiving sildenafil or other vasodilator therapy

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

• Senzaki H, Masutani S, Kobayashi J, Kobayashi T, Sasaki N, Asano H, Kyo S, Yokote Y, Ishizawa A. Ventricular afterload and ventricular work in fontan circulation: comparison with normal two-ventricle circulation and single-ventricle circulation with blalock-taussig shunts. Circulation. 2002 Jun 18;105(24):2885-92. doi: 10.1161/01.cir.0000018621.96210.72.

  PMID: 12070118 BACKGROUND

• Szabo G, Buhmann V, Graf A, Melnitschuk S, Bahrle S, Vahl CF, Hagl S. Ventricular energetics after the Fontan operation: contractility-afterload mismatch. J Thorac Cardiovasc Surg. 2003 May;125(5):1061-9. doi: 10.1067/mtc.2003.405.

  PMID: 12771880 BACKGROUND

• Tanoue Y, Sese A, Imoto Y, Joh K. Ventricular mechanics in the bidirectional glenn procedure and total cavopulmonary connection. Ann Thorac Surg. 2003 Aug;76(2):562-6. doi: 10.1016/s0003-4975(03)00467-3.

  PMID: 12902104 BACKGROUND

• Senzaki H, Masutani S, Ishido H, Taketazu M, Kobayashi T, Sasaki N, Asano H, Katogi T, Kyo S, Yokote Y. Cardiac rest and reserve function in patients with Fontan circulation. J Am Coll Cardiol. 2006 Jun 20;47(12):2528-35. doi: 10.1016/j.jacc.2006.03.022. Epub 2006 May 30.

  PMID: 16781384 BACKGROUND

• Cai J, Su Z, Shi Z, Zhou Y, Xu Z, Xu Z, Yang Y. Nitric oxide and milrinone: combined effect on pulmonary circulation after Fontan-type procedure: a prospective, randomized study. Ann Thorac Surg. 2008 Sep;86(3):882-8; discussion 882-8. doi: 10.1016/j.athoracsur.2008.05.014.

  PMID: 18721577 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeffery Meadows, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 30, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

US (1)