Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 9:08 PM
Study NCT ID:
NCT05387967
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2022-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction
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'}, {'id': 'D057911', 'term': 'Angiotensin Receptor Antagonists'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label non-randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hypotension', 'timeFrame': '12 weeks', 'description': 'Systolic blood pressure \\<90 mmHg'}, {'measure': 'Incidence of renal dysfunction', 'timeFrame': '12 weeks', 'description': 'estimated glomerular filtration rate (eGFR) \\<30 ml/min'}, {'measure': 'Incidence of renal hyperkalemia', 'timeFrame': '12 weeks', 'description': 'Potassium \\>5.2 mmol/L'}, {'measure': 'Incidence of renal angioedema', 'timeFrame': '12 weeks', 'description': 'Rapid edema, or swelling, of the area beneath the skin or mucosa'}, {'measure': 'Frequency of tolerability', 'timeFrame': 'During 12 weeks', 'description': 'Defined as the dose tolerated by the patients which did not require down titration or discontinuation of prescribed dose during follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure, Systolic']}, 'referencesModule': {'references': [{'pmid': '36915075', 'type': 'DERIVED', 'citation': 'Khan MN, Soomro NA, Naseeb K, Bhatti UH, Rauf R, Balouch IJ, Moazzam A, Bashir S, Ashraf T, Karim M. Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction. BMC Cardiovasc Disord. 2023 Mar 13;23(1):133. doi: 10.1186/s12872-023-03070-9.'}]}, 'descriptionModule': {'briefSummary': 'This proof-of-concept, open-label non-randomized clinical trial was conducted at a tertiary care cardiac center in Karachi, Pakistan. Patients with HFrEF were prescribed Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability. Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and angioedema', 'detailedDescription': "A required number of consecutive patients meeting the inclusion criteria were recruited for this study. After written informed consent patient demographic and baseline clinical characteristics were obtained. Inclusion criteria for the study were either gender between 18 to 80 years of age, diagnosed with congestive heart failure (CHF) with NYHA class II-IV, and LVEF ≤ 40%. Pre-inclusion safety parameters were patients who were stable on any dose of beta-blockers, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) prior to enrolment in the study. Patients with a baseline diagnosis of Hyperkalemia, hypotension, renal dysfunction, and a history of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes were excluded from the study.\n\nAll the recruited patients were prescribed Sacubitril/Valsartan 100mg/200mg twice a day (BID) for 6 weeks. A weekly telephonic follow-up was made to assess the patient's medication adherence level using the Dose-Nonadherence scale. All the patients were kept under a close follow-up for 6 weeks period and at the end of 12 weeks of medication, the safety and tolerability outcomes were assessed as per the operational definition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either gender\n* between 18 to 80 years of age\n* Diagnosed with Heart failure with reduced ejection fraction (HFrEF)\n* New York Heart Association (NYHA) class II-IV\n* Left ventricular ejection fraction (LVEF) ≤ 40%\n* Stable on any dose of beta-blockers, ACEI or ARB\n\nExclusion Criteria:\n\n* Refused to participate in the study\n* Patients with hyperkalemia\n* Patients with hypotension\n* Patients with renal dysfunction\n* History of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes'}, 'identificationModule': {'nctId': 'NCT05387967', 'briefTitle': 'Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Cardiovascular Diseases, Pakistan'}, 'officialTitle': 'Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction', 'orgStudyIdInfo': {'id': 'ERC-05/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.', 'interventionNames': ['Drug: Sacubitril/valsartan']}], 'interventions': [{'name': 'Sacubitril/valsartan', 'type': 'DRUG', 'otherNames': ['Angiotensin receptor blocker and neprilysin inhibitor (ARNI)'], 'description': 'All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75510', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'National Institute of Cardiovascular Diseases', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Muhammad Nauman Khan, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiovascular Diseases, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Cardiology', 'investigatorFullName': 'Dr. Muhammad Nauman Khan', 'investigatorAffiliation': 'National Institute of Cardiovascular Diseases, Pakistan'}}}}