The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients
This study has been terminated.
(Slow enrollment)
Sponsor:
INO Therapeutics
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00782652
First received: October 29, 2008
Last updated: November 4, 2008
Last verified: November 2008
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Purpose
This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction.
| Condition | Intervention | Phase |
|---|---|---|
|
Right Ventricular Infarction |
Drug: inhaled nitric oxide Drug: nitrogen gas |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by INO Therapeutics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- survival at 1 year after initial hospitalization [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]
- time on vasoconstrictor or inotropic medications [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- duration of intraaortic balloon pump support, if applicable [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- time in intensive care unit [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- duration or need for mechanical ventilation [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- change in cardiac index by dose [ Time Frame: baseline, hour 8, days 3 & 7, and at day 30 or discharge ] [ Designated as safety issue: Yes ]
- change in right ventricule function and size by dose [ Time Frame: baseline, hour 8, days 3 & 7 and at day 30 or discharge ] [ Designated as safety issue: Yes ]
- change in pulmonary vascular resistance by dose [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- change in any right-to-left intracardiac shunt flow, as assessed by contrast echocardiography [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- neurohormonal assessment of prognosis with BNP, NT-pro BNP [ Time Frame: Baseline, hour 8 and days 3 & 7 ] [ Designated as safety issue: Yes ]
- incidence of mortality [ Time Frame: treatment duration through 1 year ] [ Designated as safety issue: Yes ]
- incidence and types of reported adverse events [ Time Frame: study duration through day 30 or discharge ] [ Designated as safety issue: Yes ]
| Enrollment: | 3 |
| Study Start Date: | March 2006 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
inhaled nitric oxide at 40 or 80ppm
|
Drug: inhaled nitric oxide
Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
Other Name: INOmax
|
|
Placebo Comparator: 2
inhaled nitrogen at either 40 or 80ppm
|
Drug: nitrogen gas
Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782652
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| Belgium | |
| University Hospital Gasthuisberg, University of Leuven | |
| Leuven, Belgium, B-3000 | |
| Canada, Ontario | |
| Univeristy of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Poland | |
| Institute of Cardiology Warsaw | |
| Alpejska, Poland, 42 | |
| Spain | |
| Cardiovascular Department, Hospital Clinic | |
| Barcelona, Spain, 08036 | |
Sponsors and Collaborators
INO Therapeutics
More Information
No publications provided
| Responsible Party: | James Baldassarre, INO Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00782652 History of Changes |
| Other Study ID Numbers: | INOT43 |
| Study First Received: | October 29, 2008 |
| Last Updated: | November 4, 2008 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Belgium: Federal Gency for Medicines and Health Products Spain: Agencia Espanola del Medicamento y Productos Sanitarios Poland: Offic for Registration of Medicinal Product, Medical Devices and Biocides |
Keywords provided by INO Therapeutics:
|
myocaridal infarction right ventricular infarction cardiogenic shock RVAD Right ventricular assist device |
cardiac disease right ventricle cardiac shock heart dysfunction |
Additional relevant MeSH terms:
|
Infarction Ischemia Pathologic Processes Necrosis Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents |
Respiratory System Agents Therapeutic Uses Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013