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

Pulmonary Insufficiency Clinical Trial

Official title:

Acute Effect of Inhaled Nitric Oxide on Pulmonary Insufficiency in Congenital Heart Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543933
• Other study ID #: 07-491
• Status: Terminated
• Phase: N/A
• First received: October 11, 2007
• Last updated: January 26, 2017
• Start date: October 2007
• Est. completion date: June 2010

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inhaled nitric oxide in patients with pulmonic valve insufficiency.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Pulmonary Insufficiency

Intervention

Drug:
• iNO administered
iNO at 40 ppm through a non-rebreather mask for 5 minutes

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary regurgitant volume and fraction	Aortic regurgitant fraction measured by CMR velocity flow mapping	Single time point