Heart FailureNCT01554592
Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study
A study testing Withdrawal of statin therapy and Statin therapy in people with Heart Failure, run by The Alfred at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Withdrawal of statin therapy and Statin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18 years
- Documented heart failure of ischaemic, idiopathic or hypertensive cause
- New York Heart Association (NYHA) class II, III or IV symptoms
- LVEF < 0.40, or no more than 0.35 if NYHA class II and ischaemic aetiology.
- Receiving ACE inhibitor or ARB (Angiotensin II Receptor Blockers), β-blocker and diuretic therapy at the optimal doses.
- Has been receiving statin therapy for at least 3 months
- Willing and able to provide informed consent
Who cannot join
- Treatment with statins primarily for treatment of hypercholesterolaemia
- Obstructive or restrictive cardiomyopathy
- Uncorrected primary valvular disease
- Active myocarditis
- Decompensated heart failure or a need for inotropic therapy
- Myocardial infarction within the past 6 months
Show all 19Show fewer
- Unstable angina or stroke within the past 3 months
- 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
- Previous or planned cardiac transplantation
- Pericardial disease or systemic disease (eg amyloidosis)
- Acute or chronic liver disease
- Alanine and aspartate transminase concentrations more than 1.5 times the upper limit of normal
- Chronic muscle disease or an unexplained creatinine kinase level of more than 2.5 times the upper limit of normal
- Serum creatinine level greater than 221 micromol/L
- Previous treatment with cyclosporine
- Exercise capacity limited by factors other than cardiac dyspnoea
- Hospitalisation within one month of randomisation
- Pregnant or lactating women or women of childbearing potential who were not adequately protected against becoming pregnant
- Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial
Trial locations and contacts
1 site in 1 country.
Australia1 site
Clinical Pharmacology, Alfred Hospital
Melbourne, Victoria, 3004
About this study
Official title: 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.
Read more
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.
- Conditions
- Heart Failure
- Being tested
- Withdrawal of statin therapy, Statin therapy
- Keywords
- Heart Failure, Statin withdrawal
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of statin therapyDrug
Participants currently received statin therapy will have their statin stopped for 12 weeks.
Statin therapyDrug
Participants will continue on stable statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Statin withdrawal | Experimental | Participants will received a placebo for 12 weeks. Receives: Drug: Withdrawal of statin therapy |
| Stable statin therapy | Active comparator | Participants need to have been receiving statin therapy for at least 3 months and be on a stable dose. Receives: Drug: Statin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NYHA (New York Heart Association) Heart Failure class
Measured: baseline and after 12 weeks of treatemnt
Secondary outcomes (3)
6 minutes walk test
Measured: Baseline and after 12 weeks of treatment
Quality of life questionnaire
Measured: Baseline and after 12 weeks of treatment
Change in BNP (Brain natriuretic peptide)
Measured: Baseline and after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Hopper, The Alfred
- Investigators
- Henry Krum, MBBS FRACP PhD, Principal investigator, Alfred Hospital/Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554592
- Sponsor's protocol ID
- CP-02/12
- Status last verified
- May 2016
- First submitted
- 8 Mar 2012
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study.
- ClinicalTrials.gov ID
- NCT01554592
- Acronym / sponsor ID
- CP-02/12
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Statin withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin withdrawal | Experimental | Drug: Withdrawal of statin therapyParticipants will received a placebo for 12 weeks. |
| Stable statin therapy | Active comparator | Drug: Statin therapyParticipants need to have been receiving statin therapy for at least 3 months and be on a stable dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over the age of 18 years
- Documented heart failure of ischaemic, idiopathic or hypertensive cause
- New York Heart Association (NYHA) class II, III or IV symptoms
- LVEF < 0.40, or no more than 0.35 if NYHA class II and ischaemic aetiology.
- Receiving ACE inhibitor or ARB (Angiotensin II Receptor Blockers), β-blocker and diuretic therapy at the optimal doses.
Key exclusion criteria (19 listed)
- Treatment with statins primarily for treatment of hypercholesterolaemia
- Obstructive or restrictive cardiomyopathy
- Uncorrected primary valvular disease
- Active myocarditis
- Decompensated heart failure or a need for inotropic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of statin therapyParticipants currently received statin therapy will have their statin stopped for 12 weeks. | Drug | Statin withdrawal |
| Statin therapyParticipants will continue on stable statin therapy. | Drug | Stable statin therapy |
Primary outcome
NYHA (New York Heart Association) Heart Failure class
Time frame: baseline and after 12 weeks of treatemnt
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Krum, MBBS FRACP PhD principal investigator
Alfred Hospital/Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withdrawal of statin therapy and Statin therapy in people with Heart Failure, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NYHA (New York Heart Association) Heart Failure class (time frame: baseline and after 12 weeks of treatemnt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.