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Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease
This study is currently recruiting participants.
Verified by The Cleveland Clinic, June 2008
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00543933
  Purpose

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

MedlinePlus related topics: Heart Diseases MRI Scans
Drug Information available for: Nitric oxide
U.S. FDA Resources
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

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: June 2009
Estimated Primary Completion Date: June 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543933

Contacts
Contact: Richard Krasuski, MD (216)445-7430 krasusr@ccf.org

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

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

Study placed in the following topic categories:
Nitric Oxide
Heart Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Defects, Congenital

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009