Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-09 @ 12:22 PM
Study NCT ID:
NCT01481402
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2011-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D005067', 'term': 'Euthyroid Sick Syndromes'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014284', 'term': 'Triiodothyronine'}], 'ancestors': [{'id': 'D013970', 'term': 'Thyronines'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2011-11-25', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricle ejection fraction', 'timeFrame': '3 months', 'description': 'The effect of liothyronine treatment in low dose in 3 months on LVEF.'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '3 months', 'description': 'The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.'}, {'measure': 'Quality of Life, questionaire', 'timeFrame': '3 months', 'description': 'The effect of 3 months low dose liothyronine treatment on quality of life, assessed by SF-36 and Minnesota Living with Heart Failure questionnaires in patients with heart failure.'}, {'measure': 'YKL-40, YNF-alpha, hsCRP and IL-6', 'timeFrame': '3 months', 'description': 'The effect of 3 months low dose liothyronine treatment on low grade inflammation assessed by measurement of pro-inflammatory markers in patients with heart failure.'}, {'measure': 'RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1', 'timeFrame': '3 months', 'description': 'The effect of 3 months low dose liothyronine treatment on metabolic status in patients with heart failure.'}, {'measure': 'GDF 8, SHBG, CK and PINP', 'timeFrame': '3 months', 'description': 'The effect of 3 months low dose liothyronine treatment on the extrathyroidal thyroid effect in patients with heart failure.'}, {'measure': 'NT-proBNP, EDV and ESV', 'timeFrame': '3 months', 'description': 'The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart failure', 'Liothyronine', 'Low T3 syndrome'], 'conditions': ['Heart Failure', 'Low T3 Syndrome']}, 'descriptionModule': {'briefSummary': 'Purpose: The purpose of the study is to examine if treatment with liothyronine increases left ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.', 'detailedDescription': 'The patients are examined 3 times. At baseline, after 3 months and after 6 months.After the examination is performed, they begin the study medication while admitted at Dept. of Cardiology, Herlev Hospital, for cardiac monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stable, chronic systolic heart failure\n* T3 ≤1.4 nmol/l in two blood samples, TSH is to be normal\n* LVEF ≤ 45 % on prior echocardiography\n\nExclusion Criteria:\n\n* Established thyroid illness\n* Atrial fibrillation/flutter\n* More than 20% ventricular extrasystoles\n* Severe chronic obstructive lung disorder\n* Pregnancy. Pregnancy testing will be done for fertile women\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT01481402', 'acronym': 'LIHFA', 'briefTitle': 'Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status', 'orgStudyIdInfo': {'id': 'HerlevH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-liothyronine', 'description': '3 months of placebo followed by 3 months of Liothyronine treatment.', 'interventionNames': ['Drug: Liothyronine']}, {'type': 'OTHER', 'label': 'Liothyronine-Placebo', 'description': '3 months of Liothyronine treatment followed by 3 months of Placebo treatment.', 'interventionNames': ['Drug: Liothyronine']}], 'interventions': [{'name': 'Liothyronine', 'type': 'DRUG', 'otherNames': ['T3'], 'description': 'Liothyronine 40 microgram per day', 'armGroupLabels': ['Placebo-liothyronine']}, {'name': 'Liothyronine', 'type': 'DRUG', 'otherNames': ['T3'], 'description': '3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)', 'armGroupLabels': ['Liothyronine-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital, Dept. of Endocrinology', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Jens Faber, MDSci', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Herlev Hospital, Dept. of Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Faber', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jens Faber', 'investigatorAffiliation': 'Herlev Hospital'}}}}