Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT03553303
Status:
UNKNOWN
Last Update Posted:
2019-08-29
First Post:
2018-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurohormonal plasma concentration', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure, Systolic']}, 'descriptionModule': {'briefSummary': 'The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must give written informed consent before any study assessment is performed.\n2. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.\n3. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).\n4. Patients on optimized medical treatment for heart failure. -\n\nExclusion Criteria:\n\n1. Patients not able to comply in the study.\n2. Patients having contraindication for treatment with Entresto;\n\n 1. Hypersensitivity to the active substances or to any of the excipients listed in section\n 2. Hyperkalemia: \\> 5.4 mmol/L\n 3. Known history of angioedema related to previous ACE inhibitor or ARB therapy.\n 4. Hereditary or idiopathic angioedema.\n 5. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR \\<60 ml/min/1.73m2)\n 6. End-stage renal disease (\\<15 mL/min per 1.73m2 or treatment by dialysis).\n 7. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).\n 8. Pregnancy Breast-feeding-'}, 'identificationModule': {'nctId': 'NCT03553303', 'briefTitle': 'Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton', 'orgStudyIdInfo': {'id': '3403003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Increasing doses of Sacubitril/Valsartan', 'interventionNames': ['Drug: Sacubitril / Valsartan Oral Tablet']}], 'interventions': [{'name': 'Sacubitril / Valsartan Oral Tablet', 'type': 'DRUG', 'description': 'Increasing doses of Sacubitril/Valsartan', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3511', 'city': 'Hønefoss', 'state': 'Buskerud', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Christian Hall', 'role': 'CONTACT', 'phone': '+4747500900'}, {'name': 'Hall', 'role': 'CONTACT'}], 'facility': 'Ringerike Hospital Vestre Viken Hospital Trust', 'geoPoint': {'lat': 60.16804, 'lon': 10.25647}}], 'centralContacts': [{'name': 'Christian Hall, MD PhD', 'role': 'CONTACT', 'email': 'chall@medisin.uio.no', 'phone': '+4747500900'}, {'name': 'Ingeborg Haugli, MD', 'role': 'CONTACT', 'email': 'ingeborg.haugli@gmail.com', 'phone': '+4791887090\u202c'}], 'overallOfficials': [{'name': 'Christian Hall, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christian Hall', 'investigatorAffiliation': 'Oslo University Hospital'}}}}