Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease

This study is ongoing, but not recruiting participants.
Information provided by:
The Cleveland Clinic Identifier:
First received: October 11, 2007
Last updated: February 1, 2010
Last verified: February 2010
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
Pulmonary Insufficiency
Drug: inhaled nitric oxide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Effect of Inhaled Nitric Oxide on Pulmonary Insufficiency in Congenital Heart Disease

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Measure the severity of pulmonary insufficiency (pulmonary regurgitant volume and fraction) during the administration of inhaled nitric oxide as assessed by cardiac magnetic resonance imaging. [ Time Frame: Single time poin ] [ Designated as safety issue: No ]
  • Measure right ventricular size and function (end-systolic and end-diastolic volume, ejection fraction) during the administration of inhaled nitric oxide as assessed by cardiac magnetic resonance imaging. [ Time Frame: Single time point ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: October 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: inhaled nitric oxide
    iNO at 40 ppm through a non-rebreather mask for 5 minutes

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Known pulmonary insufficiency status
  • Previous Tetralogy of Fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis
  • Clinically indicated cardiac magnetic resonance imaging study

Exclusion Criteria:

  • Enrollment in another clinical trial
  • Age less then 18 years
  • Inability to provide informed consent
  • Institutionalized individual
  • Pregnant or lactating
  • Serious claustrophobia
  • Pacemaker/ICD
  • Aneurysm clips
  • Internal hardware
  • Severe obesity (>350lbs)
  • Residual ventricular septal defect
  • History of methemoglobinemia
  • History of blood dyscrasias
  • Acute pulmonary infection
  • Pulmonary edema
  • Hypersensitivity to nitric oxide or any of its components
  • Left ventricle dysfunction (EF<40%)
  • Concurrent use of nitroglycerin or prilocaine
  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 identifier: NCT00543933

United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Richard Krasuski, MD The Cleveland Clinic
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Richard Krasuski, Cleveland Clinic Identifier: NCT00543933     History of Changes
Other Study ID Numbers: 07-491 
Study First Received: October 11, 2007
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents processed this record on January 17, 2017