Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease
Primary Purpose
Pulmonary Insufficiency
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
iNO administered
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Insufficiency
Eligibility 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
Sites / Locations
- The Cleveland Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iNO administered
Arm Description
iNO administered at 40 ppm via a non-rebreather mask
Outcomes
Primary Outcome Measures
pulmonary regurgitant volume and fraction
Aortic regurgitant fraction measured by CMR velocity flow mapping
Secondary Outcome Measures
Full Information
NCT ID
NCT00543933
First Posted
October 11, 2007
Last Updated
January 26, 2017
Sponsor
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00543933
Brief Title
Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease
Official Title
Acute Effect of Inhaled Nitric Oxide on Pulmonary Insufficiency in Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Investigator left institution
Study Start Date
October 2007 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iNO administered
Arm Type
Experimental
Arm Description
iNO administered at 40 ppm via a non-rebreather mask
Intervention Type
Drug
Intervention Name(s)
iNO administered
Other Intervention Name(s)
Nitric Oxide
Intervention Description
iNO at 40 ppm through a non-rebreather mask for 5 minutes
Primary Outcome Measure Information:
Title
pulmonary regurgitant volume and fraction
Description
Aortic regurgitant fraction measured by CMR velocity flow mapping
Time Frame
Single time point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Krasuski, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24006858
Citation
Hart SA, Devendra GP, Kim YY, Flamm SD, Kalahasti V, Arruda J, Walker E, Boonyasirinant T, Bolen M, Setser R, Krasuski RA. PINOT NOIR: pulmonic insufficiency improvement with nitric oxide inhalational response. J Cardiovasc Magn Reson. 2013 Sep 4;15(1):75. doi: 10.1186/1532-429X-15-75.
Results Reference
derived
Learn more about this trial
Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease
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