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Sponsored by: |
The Cleveland Clinic |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00543933 |
Background: Pulmonic valve insufficiency (PI) is a well-defined problem after primary surgical repair of Tetralogy of Fallot (TOF). Though well-tolerated for years, long-term PI can lead to structural changes in the right ventricle, the sequelae of which include right heart failure, arrhythmia, and sudden cardiac death. The only current treatment for severe symptomatic PI is pulmonic valve replacement. We hypothesize that inhaled nitric oxide (iNO), a selective pulmonary vasodilator, can acutely decrease PI as assessed by cardiac magnetic resonance imaging (CMR). Methods: 22 consecutive patients with PI in the setting of corrected TOF or post pulmonic valve balloon valvuloplasty will undergo a clinically indicated CMR. Nitric oxide gas will be delivered via facemask through a specialized delivery device at 40ppm. After 5 minutes, flow velocity mapping and gradient echo sequences will be repeated to assess pulmonary regurgitant fraction, right ventricular volumes, and ejection fraction. Nitric oxide will be discontinued after acquisition of the last picture. Wilcoxon rank-sum for paired data will be used to assess effect of intervention. Significance: If decreasing pulmonary vascular resistance decreases PI, medical therapy with long-acting pulmonary vasodilators may be an attractive therapeutic option with the goal of delaying or even obviating pulmonic valve replacement.
Condition | Intervention |
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Pulmonary Insufficiency |
Drug: inhaled nitric oxide |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Acute Effect of Inhaled Nitric Oxide on Pulmonary Insufficiency in Congenital Heart Disease |
Estimated Enrollment: | 22 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard Krasuski, MD | (216)445-7430 | krasusr@ccf.org |
United States, Ohio | |
The Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Richard Krasuski, MD | The Cleveland Clinic |
Responsible Party: | Cleveland Clinic ( Dr Richard Krasuski ) |
Study ID Numbers: | 07-491 |
Study First Received: | October 11, 2007 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00543933 |
Health Authority: | United States: Institutional Review Board |
Nitric Oxide Heart Diseases Cardiovascular Abnormalities Congenital Abnormalities Heart Defects, Congenital |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Cardiovascular Diseases Peripheral Nervous System Agents Bronchodilator Agents |