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Aspirin Withdrawal in Non-ischaemic Cardiomyopathy Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Alfred
Sponsor:
Information provided by (Responsible Party):
Henry Krum, The Alfred
ClinicalTrials.gov Identifier:
NCT01534026
First received: February 2, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Aspirin
Other: withdrawal of aspirin
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534026

Contacts
Contact: Henry Krum, MBBS, FRACP, PhD +61 3 9903 0042 henry.krum@monash.edu
Contact: Marina Skiba, BEd(Sec)Sci +61 3 9076 8246 marina.skiba@monas.edu

Locations
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Henry Krum, MBBS, FRACP, PhD    +61 3 9903 0042    henry.krum@monash.edu   
Contact: Marina Skiba, BEd(Sec)Sci    +61 3 9076 8546    marina.skiba@monash.edu   
Principal Investigator: Henry Krum, MBBS, FRACP, PhD         
Sponsors and Collaborators
The Alfred
  More Information

No publications provided

Responsible Party: Henry Krum, Prof Henry Krum, The Alfred
ClinicalTrials.gov Identifier: NCT01534026     History of Changes
Other Study ID Numbers: CP-01/12
Study First Received: February 2, 2012
Last Updated: May 29, 2013
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Cardiomyopathies
Heart Failure
Cardiovascular Diseases
Heart Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014