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.|
|ClinicalTrials.gov Identifier: NCT01554592|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : June 1, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|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|
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.
- NYHA (New York Heart Association) Heart Failure class [ Time Frame: baseline and after 12 weeks of treatemnt ]
- 6 minutes walk test [ Time Frame: Baseline and after 12 weeks of treatment ]
- Quality of life questionnaire [ Time Frame: Baseline and after 12 weeks of treatment ]
- Change in BNP (Brain natriuretic peptide) [ Time Frame: Baseline and after 12 weeks of treatment ]
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 ClinicalTrials.gov identifier (NCT number): NCT01554592
|Clinical Pharmacology, Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Henry Krum, MBBS FRACP PhD||Alfred Hospital/Monash University|