Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study

Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? 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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Aspirin; Other: withdrawal of aspirin

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Over the age of 18 years
2. In sinus rhythm at the time of randomisation
3. Have a LVEF <0.40
4. Are receiving ACE inhibitor or ARB, β-blocker and diuretic therapy at the optimal doses.
5. Has been receiving aspirin therapy for at least 3 months
6. Documented non-ischaemic heart failure. Must have at least 1 of the following:
7. Willing and able to provide informed consent

Exclusion Criteria:

1. Ischaemic cardiomyopathy

2. High risk of thromboembolism, including

   • atrial fibrillation
   • previous thromboembolic event including left ventricular thrombus, stroke or transient ischaemic attack, myocardial infarction, deep venous thrombosis or pulmonary embolus
   • an underlying condition which predisposes to thromboembolism e.g. amyloidosis
   • idiopathic dilated cardiomyopathy and a history of venous thromboembolism in a first degree relative
3. Systolic BP >160mmHg
4. Uncorrected primary valvular disease
5. Active myocarditis
6. Obstructive or restrictive cardiomyopathy
7. Exercise capacity limited by factors other than cardiac dyspnoea
8. Hospitalisation within one month of randomisation
9. Severe primary pulmonary (VC <1.5L), renal or hepatic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Current dose of aspirin for 12 weeks	Drug: Aspirin; Current dose
Experimental: Withdrawal arm; Withdrawal of aspirin for 12 weeks	Other: withdrawal of aspirin; Stopping current dose of aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in NYHA class	Week 12 and week 24
Change in 6 minute walk test	12 week and 24 weeks
Change in BNP	12 weeks and 24 weeks
change in Quality of Life questionnaire	12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: The Alfred

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 30, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiomyopathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: CP-01/12