A Study of the Safety and Efficacy of Nitric Oxide Reduction in Patients With Cardiogenic Shock After a Heart Attack

Stopped early · Phase 3

Conditions studied: Shock, Cardiogenic

In brief

Tilarginine Acetate Injection is a new type of drug that temporarily stops the body from making a bodily substance called nitric oxide. The body may produce excess nitric oxide following severe heart damage leading to shock. During a heart attack, and especially after a blocked artery causing the heart attack is reopened, a large amount of nitric oxide is released into the heart muscle and into the blood. Normally small amounts of nitric oxide are good for the heart and blood vessels. However, when released in large amounts, such as during a heart attack, it may be harmful, by adding to the damage of the heart attack and lowering the heart's ability to pump blood to the body. It may cause blood pressure to be lowered and reduce the amount of blood flow to the body's vital organs. This may interfere with the body's organs being able to do their work. If Tilarginine Acetate Injection can stop extra nitric oxide from being made, the performance of the heart and blood flow to the organs may get better, which may result in the improvement of symptoms. The purpose of this study (TRIUMPH) is to investigate the safety and effectiveness of Tilarginine Acetate Injection compared to placebo (an inactive fluid that has no effect on the body but looks exactly like the medication being studied). The study will help determine whether Tilarginine Acetate Injection, by temporarily lowering the amount of nitric oxide released into the vital organs can improve blood pressure and the blood flow to the body's organs.

Key facts

Study ID

NCT00112281

Run by

Arginox Pharmaceuticals

People needed

658

Starts

2005-05-01

Expected to finish

2007-01-01

Last updated by the study team

2006-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed myocardial infarction (heart attack)
• Confirmed persistent cardiogenic shock
• Confirmed patency of the infarct related artery (heart attack artery has been opened through the use of a blood clot dissolving drug or a balloon or angioplasty heart procedure)
• Less than 24 hour duration of cardiogenic shock (the time since the heart attack occurred and the artery was opened must be less than 24 hours)

You may not qualify if…

• Infection
• Other cause of shock (not heart attack)
• Shock due to heart valve disease
• Severe heart valve disease
• Right sided heart failure
• Shock due to arrhythmia (irregular heart rhythm)
• Severe kidney disease
• Aortic dissection (tear in aorta)
• Adult respiratory distress syndrome (ARDS) (severe lung inflammation)
• Severe brain damage
• Severe irreversible multi-system failure (failure of multiple body organs)
• Major chest or abdominal surgical procedure within 30 days except if prior CABG and reocclusion occurs
• Primary pulmonary hypertension (high blood pressure in the arteries of the lungs)
• Age younger than 18 years
• Requirement for emergency coronary artery bypass grafting (CABG) or infarct-related artery occlusion (heart attack artery completely blocked)
• Ongoing or recent participation in another clinical trial of an investigational drug
• Prior enrollment in this study or rapid resolution of cardiogenic shock before treatment (shock gets better before study starts)
• Positive pregnancy test in women who are of childbearing potential

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Interventional Cardiovascular Research - Lahey Clinic — Burlington, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Fallon Cardiology - St. Vincent Hospital — Worchester, Massachusetts, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• Nisus Research at Northern Michigan Hospital — Petoskey, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• St. Mary's Duluth Clinic Health System — Duluth, Minnesota, United States
• Mayo Clinic Minnesota — Rochester, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• BryanLGH Heart Institute — Lincoln, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cooper Health System — Camden, New Jersey, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Lenox Hill Heart and Vascular Institute of New York — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Rochester Cardio-Pulmonary Group, P.C. — Rochester, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Cardiology Associates of Schenectady — Schenectady, New York, United States
• Mission Hospitals — Asheville, North Carolina, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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