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Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01554592
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
Ingrid Hopper, The Alfred

Brief Summary:

Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as a pump to move blood around the body. This sets up a complex physiologic response to compensate, which include activation of many hormonal mechanisms which result in fluid accumulation.

In recent years, medications to block the hormonal response to heart failure are given as standard drugs, and these include ACE inhibitors and beta blockers. Mortality is reduced with these medications, as well as symptoms improved. Other medications are also used in heart failure, for which a clear-cut benefit has not been demonstrated. Statins, also called HMG CoA reductase inhibitors, are used to reduce cholesterol levels and can help to prevent heart failure by preventing heart attacks. They have been used in heart failure that is not caused by heart attacks in the belief that they had "pleiotropic" effects, meaning that they had beneficial effects in heart failure separate from the reduction in cholesterol.

However large trials in heart failure have demonstrated that statins do not increase survival compared with placebo. There is no evidence to recommend their routine use in established heart failure caused by either heart attacks or genetics.

The investigators propose that the use of statins in heart failure 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. Statins are the commonest reason for side effects in patients with heart failure, causing muscle pains and gastrointestinal upset.

In this study, the investigators plan to withdraw statins from patients with stable heart failure in a closely monitored environment and watch for the effect of this on heart failure and on how they feel generally.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Withdrawal of statin therapy Drug: Statin therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study.
Study Start Date : March 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Statin withdrawal
Participants will received a placebo for 12 weeks.
Drug: Withdrawal of statin therapy
Participants currently received statin therapy will have their statin stopped for 12 weeks.

Active Comparator: Stable statin therapy
Participants need to have been receiving statin therapy for at least 3 months and be on a stable dose.
Drug: Statin therapy
Participants will continue on stable statin therapy.

Primary Outcome Measures :
  1. NYHA (New York Heart Association) Heart Failure class [ Time Frame: baseline and after 12 weeks of treatemnt ]

Secondary Outcome Measures :
  1. 6 minutes walk test [ Time Frame: Baseline and after 12 weeks of treatment ]
  2. Quality of life questionnaire [ Time Frame: Baseline and after 12 weeks of treatment ]
  3. Change in BNP (Brain natriuretic peptide) [ Time Frame: Baseline and after 12 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Over the age of 18 years
  2. Documented heart failure of ischaemic, idiopathic or hypertensive cause
  3. New York Heart Association (NYHA) class II, III or IV symptoms
  4. LVEF < 0.40, or no more than 0.35 if NYHA class II and ischaemic aetiology.
  5. Receiving ACE inhibitor or ARB (Angiotensin II Receptor Blockers), β-blocker and diuretic therapy at the optimal doses.
  6. Has been receiving statin therapy for at least 3 months
  7. Willing and able to provide informed consent

Exclusion Criteria:

  1. Treatment with statins primarily for treatment of hypercholesterolaemia
  2. Obstructive or restrictive cardiomyopathy
  3. Uncorrected primary valvular disease
  4. Active myocarditis
  5. Decompensated heart failure or a need for inotropic therapy
  6. Myocardial infarction within the past 6 months
  7. Unstable angina or stroke within the past 3 months
  8. PCI (Percutaneous coronary intervention), CABG (coronary artery bypass graft)or implantation of cardioverter-defibrillator or biventricular pacemaker within the past 3 months or a planned implantation of such a device
  9. Previous or planned cardiac transplantation
  10. Pericardial disease or systemic disease (eg amyloidosis)
  11. Acute or chronic liver disease
  12. Alanine and aspartate transminase concentrations more than 1.5 times the upper limit of normal
  13. Chronic muscle disease or an unexplained creatinine kinase level of more than 2.5 times the upper limit of normal
  14. Serum creatinine level greater than 221 micromol/L
  15. Previous treatment with cyclosporine
  16. Exercise capacity limited by factors other than cardiac dyspnoea
  17. Hospitalisation within one month of randomisation
  18. Pregnant or lactating women or women of childbearing potential who were not adequately protected against becoming pregnant
  19. Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01554592

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Australia, Victoria
Clinical Pharmacology, Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
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Principal Investigator: Henry Krum, MBBS FRACP PhD Alfred Hospital/Monash University

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Responsible Party: Ingrid Hopper, Dr Ingrid Hopper, The Alfred Identifier: NCT01554592     History of Changes
Other Study ID Numbers: CP-02/12
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by Ingrid Hopper, The Alfred:
Heart Failure
Statin withdrawal
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents