RecruitingPhase 2ACTRN12616000781448

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?


Sponsor

Cardiology Department, Queen Elizabeth Hospital

Enrollment

100 participants

Start Date

Aug 31, 2016

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing two drugs — N-acetylcysteine (NAC) and ramipril — to see if they can speed up recovery from a condition called Tako-Tsubo cardiomyopathy (TTC), also known as stress cardiomyopathy or "broken heart syndrome." TTC causes the heart muscle to temporarily weaken, usually after a stressful event. It can cause chest pain, breathlessness, dangerous heart rhythms, and can be life-threatening. There is currently no established treatment. This trial tests whether these drugs reduce heart muscle inflammation and help patients recover faster. You may be eligible if: - You are 18 years or older - You have been diagnosed with an acute episode of Tako-Tsubo cardiomyopathy - You have chest pain and/or breathlessness with heart imaging showing the typical TTC pattern - You can start NAC treatment within 24 hours of symptom onset You may NOT be eligible if: - More than 24 hours have passed since your symptoms started (for NAC component) - You have a known allergy or adverse reaction to NAC or ACE inhibitors (e.g. ramipril) - You are currently on intravenous glyceryl trinitrate (GTN) or long-acting nitrates - You have severe kidney impairment (creatinine clearance below 30 mL/min) - You have contraindications to cardiac MRI - You are unable to give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 i

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)

The Queen Elizabeth Hospital - Woodville

SA, Australia

The Royal Adelaide Hospital - Adelaide

SA, Australia

Lyell McEwin Hospital - Elizabeth Vale

SA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12616000781448


Related Trials