Can use of N-acetylcysteine and Ramipril improve clinical outcomes in Tako Tsubo Cardiomyopathy (TTC) patients? A randomised controlled trial.
Can use of N-acetylcysteine and Ramipril improve clinical outcomes in Tako Tsubo Cardiomyopathy (TTC) patients?
Cardiology Department, Queen Elizabeth Hospital
100 participants
Aug 31, 2016
Interventional
Conditions
Summary
Stress cardiomyopathy (Tako-Tsubo Cardiomyopathy; TTC) was once thought to be a relatively rare form of transient regional cardiac dysfunction, occurring largely in ageing women. Given the apparently benign course of this condition, little attention has been directed until recently to its cause, or to appropriate treatment. However, it is now apparent that TTC is neither rare nor benign and accounts for about 10% of “heart attacks” in women. Our studies have led to expedited diagnosis, and have delineated a number of aspects of the natural history of TTC. Specifically, attacks, presenting usually as episodes of chest pain and/or breathlessness, TTC actually represents a form of catecholamine-triggered myocardial(heart muscle) inflammation of varying severity, which may engender lethal arrhythmias (abnormal heart rhythms), However the main cause of death post hospital admission is the development of severe hypotension (low blood pressure), which causes death in 2 – 3% of cases. The recovery is slow, due to persistent inflammation and energetic impairment within myocardium (heart muscle), and is associated with prolonged impairment of quality of life. There is also a substantial risk of recurrence. Furthermore, we have data from post-mortem studies and from a rat model of TTC developed in our laboratory that the myocardial inflammation is associated with increased nitrosative stress. Currently, there has not been an established treatment for TTC. We wish to test the hypotheses that agents that limit nitrosative stress (such as NAC and ramipril) might:- (i) Reduce the severity of inflammation and associated myocardial energetic impairment in TTC, and (ii) Accelerate recovery from TTC
Eligibility
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Interventions
Placebo controlled trial in a 2 by 2 factorial design, studying the effects of N-acetylcystein (NAC) and Ramipril on the severity and recovery of patients with TTC. NAC component involve 24 hours of intravenous infusion of 10g of NAC/placebo, and the Ramipril component involves 10mg daily of encapsulated ramipril tablet/encapsulated placebo tablet for a duration of 3 months. Each arm of the study is as per the following: Arm 1: 24 hours of intravenous infusion of 10g of NAC at baseline and daily 10mg Ramipril for a duration of 3 months Arm 2: 24 hours of intravenous infusion of placebo at baseline and daily 10mg Ramipril for a duration of 3 months Arm 3: 24 hours of intravenous infusion of 10g of NAC at baseline and daily 10mg placebo for a duration of 3 months Arm 4: 24 hours of intravenous infusion of placebo at baseline and daily 10mg placebo for a duration of 3 months Adherence monitoring will be done by drug tablet return.
Locations(3)
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ACTRN12616000781448