Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-04-23 @ 7:46 AM
Study NCT ID:
NCT04746495
Status:
WITHDRAWN
Last Update Posted:
2023-02-21
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': '* Lab results will be reviewed by an un-blinded co-investigator.\n* Dose adjustments will be done by an un-blinded co-investigator who is licensed to prescribe the study drug.\n* The study blind will be broken on completion of the clinical study.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Issues relate to COVID-19 and staffing challenges, as well as very tight finances.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) Cycle threshold (Ct) value of mineralocorticoid receptor-regulated gene messenger ribonucleic acid (mRNA)', 'timeFrame': 'Week 6 (after first study treatment)', 'description': 'Cycle threshold of urinary mRNA biomarker following treatment with placebo and following treatment with eplerenone will be measured using RT-qPCR.'}, {'measure': 'RT-qPCR Ct value of mineralocorticoid receptor-regulated gene mRNA', 'timeFrame': 'Week 12 (after second study treatment)', 'description': 'Cycle threshold of urinary mRNA biomarker following treatment with placebo and following treatment with eplerenone will be measured using RT-qPCR.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mineralocorticoid', 'mineralocorticoid receptor', 'aldosterone', 'eplerenone', 'blood pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This blinded cross-over clinical trial will enroll participants with mild stage 1 hypertension to evaluate whether urinary extracellular transcript abundance predicts response to an mineralocorticoid receptor (MR) antagonist, eplerenone.\n\nEligible participants will have a 2 week wash-in period followed by 4 weeks of treatment with placebo or eplerenone. There will be a 2 week wash out period from study medications and then participants will take the other drug (placebo or eplerenone) for 4 weeks. In addition, participants will also provide urine and blood samples during the trial, have physical assessments, and be monitored for safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of mild stage 1 systemic hypertension as defined by:\n\n 1. Systolic blood pressure (SBP) ≥ 140 millimeters of Mercury (mmHg) or diastolic blood pressure (DBP) ≥ 90 mmHg on 2 occasions and\n 2. Treatment with 1-2 antihypertensive medications (stable dose for 6 weeks)\n\n Exclusion Criteria:\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n* Stage 2 hypertension (history of blood pressure ≥ 160/100 mmHg)\n* History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension\n* Current mineralocorticoid antagonist use\n* Type II Diabetes with microalbuminuria\n* Primary adrenal insufficiency\n* Current glucocorticoid use\n* Electrolyte abnormality on baseline laboratory assessment\n* Current potassium supplementation\n* Positive test for leukocyte esterase on urinalysis\n* Creatinine clearance \\< 50 mL/min on baseline laboratory assessment\n* Hyperkalemia\n* Potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene)\n* Serum potassium \\>5.0 milliequivalents per liter (mEq/L) on baseline laboratory assessment\n* Current use of strong CYP3A4 inhibitors (some include: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir).\n* Serum creatinine \\> 1.5 mg/dL in males on baseline laboratory assessment\n* Serum creatinine \\> 1.3 mg/dL in females\n* Current beta blocker use\n* Any other condition thought by the Principal Investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study'}, 'identificationModule': {'nctId': 'NCT04746495', 'acronym': 'ENOVA', 'briefTitle': 'Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)', 'orgStudyIdInfo': {'id': 'HUM00170418'}, 'secondaryIdInfos': [{'id': '1K23HL128909-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL128909-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be randomized to receive 4 weeks of placebo and then 4 weeks of Eplerenone.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Eplerenone', 'description': 'Participants will be randomized to receive 4 weeks of Eplerenone and then 4 weeks of Placebo.', 'interventionNames': ['Drug: Eplerenone 50mg']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will go through a 2-week wash-in period. During the wash-in period, the participant will be asked not to take their usual antihypertensive medications for their mild hypertension. After the 2-week wash-in period, the participants will begin a 4-week treatment period and will take a placebo once a day for 4 weeks. After the 4 weeks, the participants will have a 2-week wash-out period where they will be off the study treatment. After the 2-week wash-out period, the participants will begin the Eplerenone treatment for another 4 weeks.', 'armGroupLabels': ['Placebo']}, {'name': 'Eplerenone 50mg', 'type': 'DRUG', 'description': 'Participants will go through a 2-week wash-in period. During the wash-in period, the participant will be asked not to take their usual antihypertensive medications for their mild hypertension. After the 2-week wash-in period, the participants will begin a 4-week treatment period of Eplerenone for 4 weeks. After the 4 weeks, the participants will have a 2-week wash-out period where they will be off the study treatment. After the 2-week wash-out period, the participants will then begin the Placebo treatment for another 4 weeks.', 'armGroupLabels': ['Eplerenone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'J Brian Byrd, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'De-identified data will be deposited into a repository within 1 year of the conclusion of the study.', 'ipdSharing': 'YES', 'description': 'We will de-identify participant information and will share it with a trusted repository, such as National Institutes of Health (NIH) Figshare or The Inter-university Consortium for Political and Social Research (ICPSR).\n\nWe will de-identify and share data obtained from analyzing urinary mRNA biomarkers and measuring the systolic and diastolic blood pressure following consumption of a high-sodium and low-sodium diet. Additionally, specific lab values that support the validity and quality of the study treatment will be shared in a trusted repository.', 'accessCriteria': 'No additional access restrictions will be placed on the de-identified data, beyond those required by the repository to access or download the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Internal Medicine', 'investigatorFullName': 'J Brian Byrd, MD, MS', 'investigatorAffiliation': 'University of Michigan'}}}}