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.
|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? Statin Withdrawal Study.|
- NYHA (New York Heart Association) Heart Failure class [ Time Frame: baseline and after 12 weeks of treatemnt ] [ Designated as safety issue: No ]
- 6 minutes walk test [ Time Frame: Baseline and after 12 weeks of treatment ] [ Designated as safety issue: No ]
- Quality of life questionnaire [ Time Frame: Baseline and after 12 weeks of treatment ] [ Designated as safety issue: No ]
- Change in BNP (Brain natriuretic peptide) [ Time Frame: Baseline and after 12 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554592
|Contact: Henry Krum, MBBS, FRACP, PhD||+61 3 9903 email@example.com|
|Contact: Ingrid Hopper, MBBS, FRACP||+61 3 9903 firstname.lastname@example.org|
|Clinical Pharmacology, Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Henry Krum, MBBS, FRACP, PhD +61 3 9903 0042 email@example.com|
|Contact: Ingrid Hopper, MBBS, FRACP +61 3 9903 0569 firstname.lastname@example.org|
|Principal Investigator: Henry Krum, MBBS, FRACP, PhD|
|Sub-Investigator: Ingrid Hopper, MBBS, FRACP|
|Principal Investigator:||Henry Krum, MBBS FRACP PhD||Alfred Hospital/Monash University|