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