Pulmonary Insufficiency
Conditions
Brief summary
Inhaled nitric oxide in patients with pulmonic valve insufficiency.
Detailed 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.
Interventions
DRUGiNO administered
iNO at 40 ppm through a non-rebreather mask for 5 minutes
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pulmonary regurgitant volume and fraction | Single time point | Aortic regurgitant fraction measured by CMR velocity flow mapping |
Countries
United States
Outcome results
None listed