Right Ventricular InfarctionPhase 2NCT00782652
The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients
A Phase 2 study testing inhaled nitric oxide and nitrogen gas in people with Right Ventricular Infarction, run by Mallinckrodt at 6 sites in 5 countries.
Trial summary
This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Infarction
- What is being tested?
- inhaled nitric oxide and nitrogen gas
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Mar 2006to Feb 2007
- Phase
- Phase 2
- 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
- Acute inferior mycardial infarction (defined as an episode of chest pain lasting >30 minutes and electrocardiographic evidence of 1 mm or greater ST elevation in inferior leads) within the past 72 hours.
- Invasive hemodynamic evidence of hemodynamically-significant RV dysfunction, defined as the presence of all the following: systemic venous congestion (mean RA pressure > 10mmHg), the ratio of RA/PCW pressure 0.75 or greater, a low cardiac output as determined by Fick or Thermodilution (TD) technique (cardiac index < 2.5 l/min/m2), systolic systemic arterial blood pressure of 90mmHg or less or requiring vasopressor or mechanical support to maintain systolic pressure > 90mmHg. Patients with a PCWP of 14mmHg or less should receive intravascular volume repletion until their PCWP is > 14mmHg.
- Coronary angiography revealing either an occlusion of the RCA proximal to any RV marginal branch or evidence of diminished flow to RV marginal branches of the RCA.
- If patient undergoes coronary revascularization, there must be evidence of unsuccessful right ventricular reperfusion (lack of restoration of TIMI grade III flow in the distal RCA and > 1mm RV marginal branches) or evidence of hemodynamically significant RVI must persist for greater than 1 hour after successful revascularization.
- Age 18 years or greater
Who cannot join
- PCW 25mmHg or greater or mechanical complications of myocardial infarction requiring surgical correction.
- Severe LV systolic dysfunction as determined by the principal investigator. Unprotected left main coronary stenosis > 50%.
- Pulmonary infiltrates consistent with pulonary edema on chest X-ray (if chest X-ray is clinically indicated).
- Evidence of shock-related end-organ damage, including creatinine 3.0 or greater, metabolic acidosis (pH 7.1 or less) and not corrected by 100 ml NaHCO3 (1mEq/ml), disseminated intravascular coagulation, or clinical evidence of diffuse brain injury.
- Previous history of severe pericardial, congenital, or valvular heart disease.
- Refractory hemodynamically significant arrhythmia.
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- Presence of pneumonia, adult respiratory distress syndrome, or sepsis.
- Prior history of pulmonary disease requiring chronic oxygen therapy.
- Pregnancy
- Use of investigational drugs or device within the 30 days prior to enrollment to the study.
- Uncontrolled active bleeding.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
William Beaumont Hospital
Royal Oak, Michigan, 48073
Belgium1 site
University Hospital Gasthuisberg, University of Leuven
Leuven, B-3000
About this study
Official title: The Effects of Nitric Oxide for Inhalation on Survival or the Need for Dialysis or a Right Ventricular Assistance Device (RVAD) in Right Ventricular Infarction Patients
This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction.
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled study that will assess the feasibility of studying inhaled nitric oxide for the treatment of cardiogenic shock due to right ventricular infarction, and the dose response of the acute hemodynamic changes occurring with nitric oxide inhalation in these patients. Patients with evidence of right ventricular infarction and cardiogenic shock, and have angiographic evidence of impaired blood flow to the right ventricle, or if right ventricular coronary perfusion is unimpared, cardiac shock persists, will be eligible for enrollment. Patients will receive standard of care for their condition, and will also recieve either nitric oxide for inhalation or placebo for up to 14 days.
- Conditions
- Right Ventricular Infarction
- Being tested
- inhaled nitric oxide, nitrogen gas
- Keywords
- myocaridal infarction, right ventricular infarction, cardiogenic shock, RVAD, Right ventricular assist device, cardiac disease, right ventricle, cardiac shock, heart dysfunction
- Medical subject headings
- Shock, Cardiogenic, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled nitric oxideDrug
Also called INOmax
Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
nitrogen gasDrug
Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | inhaled nitric oxide at 40 or 80ppm Receives: Drug: inhaled nitric oxide |
| 2 | Placebo comparator | inhaled nitrogen at either 40 or 80ppm Receives: Drug: nitrogen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival to hospital discharge or Day 30, whichever occurs first without the need for renal replacement therapy or a Right Ventricular Assistance Device (RVAD)
Measured: hospital discharge or Day 30
Secondary outcomes (12)
survival at 1 year after initial hospitalization
Measured: 1 year post treatment
time on vasoconstrictor or inotropic medications
Measured: study duration
duration of intraaortic balloon pump support, if applicable
Measured: study duration
time in intensive care unit
Measured: study duration
duration or need for mechanical ventilation
Measured: study duration
change in cardiac index by dose
Measured: baseline, hour 8, days 3 & 7, and at day 30 or discharge
change in right ventricule function and size by dose
Measured: baseline, hour 8, days 3 & 7 and at day 30 or discharge
change in pulmonary vascular resistance by dose
Measured: study duration
change in any right-to-left intracardiac shunt flow, as assessed by contrast echocardiography
Measured: study duration
neurohormonal assessment of prognosis with BNP, NT-pro BNP
Measured: Baseline, hour 8 and days 3 & 7
incidence of mortality
Measured: treatment duration through 1 year
incidence and types of reported adverse events
Measured: study duration through day 30 or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startMar 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular InfarctionStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782652
- Sponsor's protocol ID
- INOT43
- Status last verified
- Sep 2016
- First submitted
- 29 Oct 2008
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nitric Oxide for Inhalation on Survival or the Need for Dialysis or a Right Ventricular Assistance Device (RVAD) in Right Ventricular Infarction Patients
- ClinicalTrials.gov ID
- NCT00782652
- Acronym / sponsor ID
- INOT43
- Conditions
- Right Ventricular Infarction
- Keywords
- myocaridal infarction, right ventricular infarction, cardiogenic shock, RVAD, Right ventricular assist device, cardiac disease, right ventricle, cardiac shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 31 Oct 2008 (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.
This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction.
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled study that will assess the feasibility of studying inhaled nitric oxide for the treatment of cardiogenic shock due to right ventricular infarction, and the dose response of the acute hemodynamic changes occurring with nitric oxide inhalation in these patients. Patients with evidence of right ventricular infarction and cardiogenic shock, and have angiographic evidence of impaired blood flow to the right ventricle, or if right ventricular coronary perfusion is unimpared, cardiac shock persists, will be eligible for enrollment. Patients will receive standard of care for their condition, and will also recieve either nitric oxide for inhalation or placebo for up to 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: inhaled nitric oxideinhaled nitric oxide at 40 or 80ppm |
| 2 | Placebo comparator | Drug: nitrogen gasinhaled nitrogen at either 40 or 80ppm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute inferior mycardial infarction (defined as an episode of chest pain lasting >30 minutes and electrocardiographic evidence of 1 mm or greater ST elevation in inferior leads) within the past 72 hours.
- Invasive hemodynamic evidence of hemodynamically-significant RV dysfunction, defined as the presence of all the following: systemic venous congestion (mean RA pressure > 10mmHg), the ratio of RA/PCW pressure 0.75 or greater, a low cardiac output as determined by Fick or Thermodilution (TD) technique (cardiac index < 2.5 l/min/m2), systolic systemic arterial blood pressure of 90mmHg or less or requiring vasopressor or mechanical support to maintain systolic pressure > 90mmHg. Patients with a PCWP of 14mmHg or less should receive intravascular volume repletion until their PCWP is > 14mmHg.
- Coronary angiography revealing either an occlusion of the RCA proximal to any RV marginal branch or evidence of diminished flow to RV marginal branches of the RCA.
- If patient undergoes coronary revascularization, there must be evidence of unsuccessful right ventricular reperfusion (lack of restoration of TIMI grade III flow in the distal RCA and > 1mm RV marginal branches) or evidence of hemodynamically significant RVI must persist for greater than 1 hour after successful revascularization.
- Age 18 years or greater
Key exclusion criteria (11 listed)
- PCW 25mmHg or greater or mechanical complications of myocardial infarction requiring surgical correction.
- Severe LV systolic dysfunction as determined by the principal investigator. Unprotected left main coronary stenosis > 50%.
- Pulmonary infiltrates consistent with pulonary edema on chest X-ray (if chest X-ray is clinically indicated).
- Evidence of shock-related end-organ damage, including creatinine 3.0 or greater, metabolic acidosis (pH 7.1 or less) and not corrected by 100 ml NaHCO3 (1mEq/ml), disseminated intravascular coagulation, or clinical evidence of diffuse brain injury.
- Previous history of severe pericardial, congenital, or valvular heart disease.
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 |
|---|---|---|
| inhaled nitric oxideAlso: INOmaxContinuous delivery at either 40 or 80 ppm for a duration of up to 14 days | Drug | 1 |
| nitrogen gasContinuous delivery at either 40 or 80 ppm for a duration of up to 14 days | Drug | 2 |
Primary outcome
survival to hospital discharge or Day 30, whichever occurs first without the need for renal replacement therapy or a Right Ventricular Assistance Device (RVAD)
Time frame: hospital discharge or Day 30
12 secondary outcomes
survival at 1 year after initial hospitalization
Time frame: 1 year post treatment
time on vasoconstrictor or inotropic medications
Time frame: study duration
duration of intraaortic balloon pump support, if applicable
Time frame: study duration
time in intensive care unit
Time frame: study duration
duration or need for mechanical ventilation
Time frame: study duration
change in cardiac index by dose
Time frame: baseline, hour 8, days 3 & 7, and at day 30 or discharge
change in right ventricule function and size by dose
Time frame: baseline, hour 8, days 3 & 7 and at day 30 or discharge
change in pulmonary vascular resistance by dose
Time frame: study duration
change in any right-to-left intracardiac shunt flow, as assessed by contrast echocardiography
Time frame: study duration
neurohormonal assessment of prognosis with BNP, NT-pro BNP
Time frame: Baseline, hour 8 and days 3 & 7
incidence of mortality
Time frame: treatment duration through 1 year
incidence and types of reported adverse events
Time frame: study duration through day 30 or discharge
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inhaled nitric oxide and nitrogen gas in people with Right Ventricular Infarction, run by Mallinckrodt at 6 sites in 5 countries.
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 5 inclusion and 11 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Belgium, Canada, Poland, Spain. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Slow enrollment). 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?
survival to hospital discharge or Day 30, whichever occurs first without the need for renal replacement therapy or a Right Ventricular Assistance Device (RVAD) (time frame: hospital discharge or Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2016.