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

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ClinicalTrials.gov Identifier: NCT00782652
Recruitment Status : Terminated (Slow enrollment)
First Posted : October 31, 2008
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

October 29, 2008
October 31, 2008
September 9, 2016
March 2006
February 2007   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00782652 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effects of Nitric Oxide for Inhalation in Right Ventricular Infarction Patients
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Right Ventricular Infarction
  • Drug: inhaled nitric oxide
    Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
    Other Name: INOmax
  • Drug: nitrogen gas
    Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
  • Active Comparator: 1
    inhaled nitric oxide at 40 or 80ppm
    Intervention: Drug: inhaled nitric oxide
  • Placebo Comparator: 2
    inhaled nitrogen at either 40 or 80ppm
    Intervention: Drug: nitrogen gas
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
Same as current
February 2007
February 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Poland,   Spain,   United States
 
 
NCT00782652
INOT43
Yes
Not Provided
Not Provided
Mallinckrodt
Mallinckrodt
Not Provided
Not Provided
Mallinckrodt
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP