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

NeuroTherapia, Inc.

Status and phase: Terminated; Early Phase 1

Conditions: Pulmonary Insufficiency

Treatments: Drug: iNO administered

Study type: Interventional

Funder types: Other

Identifiers

NCT00543933

07-491

Details and patient eligibility

About

Inhaled nitric oxide in patients with pulmonic valve insufficiency.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

iNO administered

Experimental group

Description:

iNO administered at 40 ppm via a non-rebreather mask

Treatment:

Drug: iNO administered