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

Sponsor

Mallinckrodt (Industry)

Overall Status

Terminated

CT.gov ID

NCT00782652

Collaborator

(none)

Enrollment

Locations

Arms

11.1

Duration (Months)

0.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Right Ventricular Infarction	Drug: inhaled nitric oxide Drug: nitrogen gas	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

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) [hospital discharge or Day 30]

Secondary Outcome Measures

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]
change in cardiac index by dose [baseline, hour 8, days 3 & 7, and at day 30 or discharge]
change in right ventricule function and size by dose [baseline, hour 8, days 3 & 7 and at day 30 or discharge]
change in pulmonary vascular resistance by dose [study duration]
change in any right-to-left intracardiac shunt flow, as assessed by contrast echocardiography [study duration]
neurohormonal assessment of prognosis with BNP, NT-pro BNP [Baseline, hour 8 and days 3 & 7]
incidence of mortality [treatment duration through 1 year]
incidence and types of reported adverse events [study duration through day 30 or discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
3	University Hospital Gasthuisberg, University of Leuven	Leuven		Belgium	B-3000
4	Univeristy of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
5	Institute of Cardiology Warsaw	Alpejska		Poland	42
6	Cardiovascular Department, Hospital Clinic	Barcelona		Spain	08036