Congenital Heart Disease Clinical Trial
Official title:
The Effect of Selective Pulmonary Vasodilation on Ventricular Afterload and Ventricular-arterial Coupling in Patients With Fontan Physiology and Validation of Echocardiographic Measures of Systolic and Diastolic Function.
NCT number | NCT01607983 |
Other study ID # | 11-06070 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | December 2017 |
Verified date | May 2018 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 60 Years |
Eligibility |
Inclusion Criteria: - All consecutive patients with single ventricle hearts having passive pulmonary blood flow presenting to the cardiac catheterization laboratory for clinically indicated cardiac catheterization. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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. — View Citation
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. Epub 2006 May 30. — View Citation
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. Retraction in: Circulation. 2012 Jun 12;125(23):e1020. — View Citation
Szabó G, Buhmann V, Graf A, Melnitschuk S, Bährle S, Vahl CF, Hagl S. Ventricular energetics after the Fontan operation: contractility-afterload mismatch. J Thorac Cardiovasc Surg. 2003 May;125(5):1061-9. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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