NCT00543933

Brief Summary

Inhaled nitric oxide in patients with pulmonic valve insufficiency.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2007

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

October 11, 2007

Last Update Submit

January 26, 2017

Conditions

Pulmonary Insufficiency

Outcome Measures

Primary Outcomes (1)

  • pulmonary regurgitant volume and fraction

    Aortic regurgitant fraction measured by CMR velocity flow mapping

    Single time point

Study Arms (1)

iNO administered

EXPERIMENTAL

iNO administered at 40 ppm via a non-rebreather mask

Drug: iNO administered

Interventions

iNO administeredDRUG

iNO at 40 ppm through a non-rebreather mask for 5 minutes

Also known as: Nitric Oxide
iNO administered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known pulmonary insufficiency status
  • Previous Tetralogy of Fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis
  • Clinically indicated cardiac magnetic resonance imaging study

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

    PMID: 24006858DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic Chemicals

Study Officials

  • Richard Krasuski, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 15, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)