Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-01 @ 3:39 PM
Study NCT ID:
NCT01554592
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2012-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-30', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NYHA (New York Heart Association) Heart Failure class', 'timeFrame': 'baseline and after 12 weeks of treatemnt'}], 'secondaryOutcomes': [{'measure': '6 minutes walk test', 'timeFrame': 'Baseline and after 12 weeks of treatment'}, {'measure': 'Quality of life questionnaire', 'timeFrame': 'Baseline and after 12 weeks of treatment'}, {'measure': 'Change in BNP (Brain natriuretic peptide)', 'timeFrame': 'Baseline and after 12 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Statin withdrawal'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nHowever 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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over the age of 18 years\n2. Documented heart failure of ischaemic, idiopathic or hypertensive cause\n3. New York Heart Association (NYHA) class II, III or IV symptoms\n4. LVEF \\< 0.40, or no more than 0.35 if NYHA class II and ischaemic aetiology.\n5. Receiving ACE inhibitor or ARB (Angiotensin II Receptor Blockers), β-blocker and diuretic therapy at the optimal doses.\n6. Has been receiving statin therapy for at least 3 months\n7. Willing and able to provide informed consent\n\nExclusion Criteria:\n\n1. Treatment with statins primarily for treatment of hypercholesterolaemia\n2. Obstructive or restrictive cardiomyopathy\n3. Uncorrected primary valvular disease\n4. Active myocarditis\n5. Decompensated heart failure or a need for inotropic therapy\n6. Myocardial infarction within the past 6 months\n7. Unstable angina or stroke within the past 3 months\n8. 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\n9. Previous or planned cardiac transplantation\n10. Pericardial disease or systemic disease (eg amyloidosis)\n11. Acute or chronic liver disease\n12. Alanine and aspartate transminase concentrations more than 1.5 times the upper limit of normal\n13. Chronic muscle disease or an unexplained creatinine kinase level of more than 2.5 times the upper limit of normal\n14. Serum creatinine level greater than 221 micromol/L\n15. Previous treatment with cyclosporine\n16. Exercise capacity limited by factors other than cardiac dyspnoea\n17. Hospitalisation within one month of randomisation\n18. Pregnant or lactating women or women of childbearing potential who were not adequately protected against becoming pregnant\n19. Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial'}, 'identificationModule': {'nctId': 'NCT01554592', 'briefTitle': 'Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study.', 'orgStudyIdInfo': {'id': 'CP-02/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Statin withdrawal', 'description': 'Participants will received a placebo for 12 weeks.', 'interventionNames': ['Drug: Withdrawal of statin therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stable statin therapy', 'description': 'Participants need to have been receiving statin therapy for at least 3 months and be on a stable dose.', 'interventionNames': ['Drug: Statin therapy']}], 'interventions': [{'name': 'Withdrawal of statin therapy', 'type': 'DRUG', 'description': 'Participants currently received statin therapy will have their statin stopped for 12 weeks.', 'armGroupLabels': ['Statin withdrawal']}, {'name': 'Statin therapy', 'type': 'DRUG', 'description': 'Participants will continue on stable statin therapy.', 'armGroupLabels': ['Stable statin therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Pharmacology, Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Henry Krum, MBBS FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred Hospital/Monash University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Ingrid Hopper', 'investigatorFullName': 'Ingrid Hopper', 'investigatorAffiliation': 'The Alfred'}}}}