Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study
Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as a pump to move blood around the body. Aspirin has been traditionally used in heart failure because a tendency towards blood clots (including stroke and heart attack, clots in the legs and in the lungs) has been observed in this group and aspirin's mechanism of action is to prevent blood clots. This is important because two-thirds of cases of heart failure are caused by a blood clot in the coronary artery resulting in a heart attack, and aspirin is given to reduce the chances of further heart attacks.
However aspirin was introduced before clinical trials as the investigators know them now were run. Systematic review of the trials of aspirin in heart failure has shown that its use does not increase survival, and there is no evidence to recommend its routine use. Another important finding was that use of aspirin may reduce the beneficial effects of ACE inhibitors which do have a mortality benefit, and that aspirin was associated with an increase in hospitalisation for heart failure compared to other drugs which prevent clots or placebo.
The investigators propose that the use of aspirin in heart failure that is not caused by heart attacks ("non-ischaemic cardiomyopathy") is unnecessary and could be stopped. The importance of finding evidence to cease unproven medications in heart failure cannot be understated. Patients with heart failure take an average of six prescription medications each day. Each medication has side effects and the interactions of all the drugs together are unknown. Aspirin itself is a drug which frequently has side effects of increased risk of bleeding, gastrointestinal ulceration, as well as kidney impairment.
In this study, the investigators plan to withdraw aspirin from patients with stable non-ischaemic heart failure in a closely monitored environment and watch for the effect of this on heart failure.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study|
- Change in NYHA class [ Time Frame: Week 12 and week 24 ] [ Designated as safety issue: Yes ]
- Change in 6 minute walk test [ Time Frame: 12 week and 24 weeks ] [ Designated as safety issue: Yes ]
- Change in BNP [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
- change in Quality of Life questionnaire [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Aspirin
Current dose of aspirin for 12 weeks
Experimental: Withdrawal arm
Withdrawal of aspirin for 12 weeks
Other: withdrawal of aspirin
Stopping current dose of aspirin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534026
|Contact: Henry Krum, MBBS, FRACP, PhD||+61 3 9903 firstname.lastname@example.org|
|Contact: Marina Skiba, BEd(Sec)Sci||+61 3 9076 email@example.com|
|The Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Henry Krum, MBBS, FRACP, PhD +61 3 9903 0042 firstname.lastname@example.org|
|Contact: Marina Skiba, BEd(Sec)Sci +61 3 9076 8546 email@example.com|
|Principal Investigator: Henry Krum, MBBS, FRACP, PhD|