Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary In... | NCT00543933

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

NCT00543933

Sponsor

The Cleveland Clinic

Status

Terminated

Last Update Posted

Jan 27, 2017Estimated

Enrollment

18Actual

Phase

Early Phase 1

Conditions

Pulmonary Insufficiency

Interventions

iNO administered

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator left institution

Expanded Access Info

Start Date

Oct 2007Actual

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Oct 11, 2007

First Submission Date that Met QC Criteria

Oct 11, 2007

First Posted Date

Oct 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2017

Last Update Posted Date

Jan 27, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iNO administered	Experimental	iNO administered at 40 ppm via a non-rebreather mask	Drug: iNO administered

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iNO administered	Drug	iNO at 40 ppm through a non-rebreather mask for 5 minutes	iNO administered

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pulmonary regurgitant volume and fraction	Aortic regurgitant fraction measured by CMR velocity flow mapping	Single time point

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Krasuski, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Cleveland Clinic		Cleveland	Ohio	44195	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24006858	Derived	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.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D026361	Reactive Nitrogen Species
D005609	Free Radicals
D007287	Inorganic Chemicals
D009589	Nitrogen Oxides