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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01554592




Registration number
NCT01554592
Ethics application status
Date submitted
8/03/2012
Date registered
15/03/2012
Date last updated
1/06/2016

Titles & IDs
Public title
Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study
Scientific title
Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study.
Secondary ID [1] 0 0
CP-02/12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Withdrawal of statin therapy
Treatment: Drugs - Statin therapy

Experimental: Statin withdrawal - Participants will received a placebo 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.


Treatment: Drugs: Withdrawal of statin therapy
Participants currently received statin therapy will have their statin stopped for 12 weeks.

Treatment: Drugs: Statin therapy
Participants will continue on stable statin therapy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
NYHA (New York Heart Association) Heart Failure class
Timepoint [1] 0 0
baseline and after 12 weeks of treatemnt
Secondary outcome [1] 0 0
6 minutes walk test
Timepoint [1] 0 0
Baseline and after 12 weeks of treatment
Secondary outcome [2] 0 0
Quality of life questionnaire
Timepoint [2] 0 0
Baseline and after 12 weeks of treatment
Secondary outcome [3] 0 0
Change in BNP (Brain natriuretic peptide)
Timepoint [3] 0 0
Baseline and after 12 weeks of treatment

Eligibility
Key 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), ß-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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Clinical Pharmacology, Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01554592
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS FRACP PhD
Address 0 0
Alfred Hospital/Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01554592