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

NCT00782652 | Terminated Phase 2 DMC

• 1 other identifier: INOT43
• Study Type: interventional
• Target: 3
• Locations: 5 countries
• Sites: 6

Brief Summary

This study is designed to better understand the effects of nitric oxide, a gas for inhalation, on patients with right ventricular infarction.

Conditions

Right Ventricular Infarction

Keywords

myocaridal infarction; right ventricular infarction; cardiogenic shock; RVAD; Right ventricular assist device; cardiac disease; right ventricle; cardiac shock; heart dysfunction

Outcome Measures

Primary Outcomes (1)

• survival to hospital discharge or Day 30, whichever occurs first without the need for renal replacement therapy or a Right Ventricular Assistance Device (RVAD)

  hospital discharge or Day 30

Secondary Outcomes (12)

• survival at 1 year after initial hospitalization

  1 year post treatment

• time on vasoconstrictor or inotropic medications

  study duration

• duration of intraaortic balloon pump support, if applicable

  study duration

• time in intensive care unit

  study duration

• duration or need for mechanical ventilation

  study duration

Study Arms (2)

1

ACTIVE COMPARATOR

inhaled nitric oxide at 40 or 80ppm

Drug: inhaled nitric oxide

2

PLACEBO COMPARATOR

inhaled nitrogen at either 40 or 80ppm

Drug: nitrogen gas

Interventions

inhaled nitric oxide DRUG

Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days

Also known as: INOmax

1

nitrogen gas DRUG

Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University Hospital Gasthuisberg, University of Leuven

Leuven, B-3000, Belgium

Location

Univeristy of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Institute of Cardiology Warsaw

Alpejska, 42, Poland

Location

Cardiovascular Department, Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Diseases

Interventions

Endothelium-Dependent Relaxing Factors; Nitrogen

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: March 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

ES (1); CA (1); US (2); BE (1); PL (1)