Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-08 @ 7:47 AM
Study NCT ID:
NCT04190433
Status:
WITHDRAWN
Last Update Posted:
2023-05-24
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}, {'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D000085', 'term': 'Acetates'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Administratively closed due to low/no accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta change in left ventricular ejection fraction [LVEF])', 'timeFrame': 'Baseline up to 6 months', 'description': 'Will be a comparison of the average delta change in LVEF from start to six months of therapy between group 1 and 2 via an independent groups t-test or Wilcoxon as appropriate after testing distributional assumptions.'}], 'secondaryOutcomes': [{'measure': 'Cardiac function recovery rates between group 1 and group 2', 'timeFrame': 'Baseline up to 6 months', 'description': 'Incidence rates will be compared using a simple test for equality of binomial proportions (χ \\^ 2 -test or Fisher Exact).'}, {'measure': 'Time to recovery of cardiac function between group 1 and group 2', 'timeFrame': 'Baseline up to 6 months', 'description': 'Will be a comparison of the average delta change in LVEF from start to six months of therapy between group 1 and 2 via an independent groups t-test or Wilcoxon as appropriate after testing distributional assumptions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma', 'Hematopoietic and Lymphoid Cell Neoplasm', 'Lymphoma', 'Sarcoma']}, 'descriptionModule': {'briefSummary': 'This phase II trial compares two drug therapy plans for the correction of heart function changes (reduced ejection function) in patients who have undergone anthracycline-based treatment for lymphoma, sarcoma, or breast cancer. "Reduced ejection fraction" means the left ventricle of the heart is pumping a reduced blood volume with each heartbeat. Treatment is recommended, and the purpose of this research is to compare two different drug therapy plans (standard therapy with carvedilol and lisinopril and standard therapy with carvedilol and lisinopril plus pravastatin and spironolactone) and their effects on improvement of heart function. All of these drugs are heart medications, and carvedilol and lisinopril are commonly used to improve heart function. Adding pravastatin, a cholesterol lowering drug with additional beneficial effects on the cardiovascular system, and spironolactone, a water pill with additional beneficial effects on the cardiovascular system, may lead to even better (and faster) improvements in heart function.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To compare cardiac function changes (delta left ventricular ejection fraction \\[LVEF\\]) over six months in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.\n\nSECONDARY OBJECTIVE:\n\nI. To compare cardiac function recovery rates over six months in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma, sarcoma, or breast cancer randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.\n\nII. To compare the time to recovery of cardiac function in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma, sarcoma, or breast cancer randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.\n\nOUTLINE: Patients are randomized in to 1 of 2 groups.\n\nGROUP I: Patients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.\n\nGROUP II: Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.\n\nAfter completion of study treatment, patients are followed up at the 6 month visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 years of age.\n* New diagnosis of reduced cardiac function.\n* Any prior anthracycline-based cancer therapy for hematological malignancy, breast cancer, or sarcoma.\n\nExclusion Criteria:\n\n* History of heart failure (HF) of any class and type, or diagnosis of cardiomyopathy prior to anthracycline therapy.\n* On active therapy with a fibrate, niacin or eplerenone, or statin.\n* History of myopathy/rhabdomyolysis.\n* History of statin intolerance.\n* Active treatment for hyperlipidemia.\n* History of gout.\n* Active treatment for liver disease.\n* Unexplained persistent elevations of serum transaminases (above upper limit of normal over two weeks).\n* Pregnancy.\n* Breast-feeding.\n* Hyperkalemia (above upper limit of normal).\n* Addison disease.\n* Estimated glomerular filtration rate (eGFR) \\< 30 mL/minute/1.73 m\\^2.'}, 'identificationModule': {'nctId': 'NCT04190433', 'briefTitle': 'Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial', 'orgStudyIdInfo': {'id': '19-007547'}, 'secondaryIdInfos': [{'id': 'NCI-2021-13928', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (carvedilol, lisinopril)', 'description': 'Patients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.', 'interventionNames': ['Drug: Carvedilol', 'Drug: Lisinopril']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (pravastatin, spironolactone)', 'description': 'Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.', 'interventionNames': ['Drug: Carvedilol', 'Drug: Lisinopril', 'Drug: Pravastatin', 'Drug: Spironolactone']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'otherNames': ['Coreg'], 'description': 'Given PO', 'armGroupLabels': ['Group I (carvedilol, lisinopril)', 'Group II (pravastatin, spironolactone)']}, {'name': 'Lisinopril', 'type': 'DRUG', 'otherNames': ['N2-[(1S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline, Dihydrate', 'Prinivil', 'Zestril'], 'description': 'Given PO', 'armGroupLabels': ['Group I (carvedilol, lisinopril)', 'Group II (pravastatin, spironolactone)']}, {'name': 'Pravastatin', 'type': 'DRUG', 'otherNames': ['[1S-[1alpha(betaS*,deltaS*),2alpha,6alpha,8beta(R*),8aalpha]]-1,2,6,7,8,8a-Hexahydro-beta,!d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-1-naphthaleneheptanoic Acid'], 'description': 'Given PO', 'armGroupLabels': ['Group II (pravastatin, spironolactone)']}, {'name': 'Spironolactone', 'type': 'DRUG', 'otherNames': ['17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate', 'Aldactone', 'SC 9420', 'SPL'], 'description': 'Given PO', 'armGroupLabels': ['Group II (pravastatin, spironolactone)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joerg Herrmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}