Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01554592