The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00782652
First received: October 29, 2008
Last updated: November 4, 2008
Last verified: November 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014