Pulmonary InsufficiencyEarly Phase 1NCT00543933
Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease
A Early Phase 1 study testing iNO administered in people with Pulmonary Insufficiency, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Inhaled nitric oxide in patients with pulmonic valve insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Insufficiency
- What is being tested?
- iNO administered
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known pulmonary insufficiency status
- Previous Tetralogy of Fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis
- Clinically indicated cardiac magnetic resonance imaging study
Who cannot join
- Enrollment in another clinical trial
- Age less then 18 years
- Inability to provide informed consent
- Institutionalized individual
- Pregnant or lactating
- Serious claustrophobia
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Inhaled Nitric Oxide on Pulmonary Insufficiency in Congenital Heart Disease
Inhaled nitric oxide in patients with pulmonic valve insufficiency.
Read the 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.
- Conditions
- Pulmonary Insufficiency
- Being tested
- iNO administered
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNO administeredDrug
Also called Nitric Oxide
iNO at 40 ppm through a non-rebreather mask for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| iNO administered | Experimental | iNO administered at 40 ppm via a non-rebreather mask Receives: Drug: iNO administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary regurgitant volume and fraction
Aortic regurgitant fraction measured by CMR velocity flow mapping
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary InsufficiencyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Krasuski, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543933
- Sponsor's protocol ID
- 07-491
- Status last verified
- Jan 2017
- First submitted
- 11 Oct 2007
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24006858
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Inhaled Nitric Oxide on Pulmonary Insufficiency in Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00543933
- Acronym / sponsor ID
- 07-491
- Conditions
- Pulmonary Insufficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNO administered | Experimental | Drug: iNO administerediNO administered at 40 ppm via a non-rebreather mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known pulmonary insufficiency status
- Previous Tetralogy of Fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis
- Clinically indicated cardiac magnetic resonance imaging study
Key exclusion criteria (18 listed)
- Enrollment in another clinical trial
- Age less then 18 years
- Inability to provide informed consent
- Institutionalized individual
- Pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iNO administeredAlso: Nitric OxideiNO at 40 ppm through a non-rebreather mask for 5 minutes | Drug | iNO administered |
Primary outcome
pulmonary regurgitant volume and fraction
Time frame: Single time point
Aortic regurgitant fraction measured by CMR velocity flow mapping
Results and safety
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Derived from this study: PubMed 24006858Hart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Krasuski, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing iNO administered in people with Pulmonary Insufficiency, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary regurgitant volume and fraction (time frame: Single time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00543933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.