Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-03 @ 4:33 AM
Study NCT ID:
NCT02779634
Status:
UNKNOWN
Last Update Posted:
2016-05-20
First Post:
2016-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003741', 'term': 'ubiquinol'}, {'id': 'C024989', 'term': 'coenzyme Q10'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2016-05-15', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography', 'timeFrame': '4 months'}, {'measure': 'NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml)', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '34826125', 'type': 'DERIVED', 'citation': 'Samuel TY, Hasin T, Gotsman I, Weitzman T, Ben Ivgi F, Dadon Z, Asher E, Amir O, Glikson M, Alcalai R, Leibowitz D. Coenzyme Q10 in the Treatment of Heart Failure with Preserved Ejection Fraction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Drugs R D. 2022 Mar;22(1):25-33. doi: 10.1007/s40268-021-00372-1. Epub 2021 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on echocardiographic indices of diastolic function in elderly patients with heart failure with preserved ejection fraction (HFPEF). In previous studies the only echocardiographic parameters studied were ejection fraction (EF) and chamber size. The objective of the proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic function assessed by echocardiography in patients over the age of 50 with a clinical diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for this study as it has been shown to have superior bioavailability when compared to oxidized CoQ.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Typical signs and symptoms of congestive heart failure (CHF) (New York Association Class 2-4).\n* Normal ejection fraction on echocardiography (EF ≥50%).\n* Evidence of diastolic dysfunction on non-invasive imaging (E:e' \\> 15 or e:e' \\> 8 with other measures of diastolic dysfunction such as e/a \\< 0.5 with elevated deceleration time or left atrial volume index \\> 40 cc/m2 or presence of elevated left ventricular mass index or elevated pulmonary pressures).\n* Stable medical therapy for 4 weeks prior to randomization\n\nExclusion Criteria:\n\n* Chronic atrial fibrillation.\n* Acute coronary syndrome or coronary revascularization within 60 days.\n* Clinically significant valvular disease.\n* Known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease.\n* Inability/refusal to provide informed consent"}, 'identificationModule': {'nctId': 'NCT02779634', 'briefTitle': 'Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'The Effect of Ubiquinol Treatment on Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'COENZYMEQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo three times daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Pills of 100 mg ubiquinol three times daily', 'interventionNames': ['Drug: ubiquinol']}], 'interventions': [{'name': 'ubiquinol', 'type': 'DRUG', 'otherNames': ['coenzyme Q10'], 'description': 'Ubiquinol three times daily', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pill three times daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sara Elias', 'role': 'CONTACT', 'email': 'sarae@hadassah.org.il'}], 'overallOfficials': [{'name': 'David Leibowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of medicine Hadassah-Hebrew University Medical Center', 'investigatorFullName': 'LEIBOWITZ DAVID', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}