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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3
Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
Continuous delivery at either 40 or 80 ppm for a duration of up to 14 days
Massachusetts General Hospital
Boston, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University Hospital Gasthuisberg, University of Leuven
Leuven, Belgium
Univeristy of Ottawa Heart Institute
Ottawa, Ontario, Canada
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
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
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Institute of Cardiology Warsaw
Alpejska, Poland
Cardiovascular Department, Hospital Clinic
Barcelona, Spain
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