Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04218435
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2019-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2019-12-27', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire', 'timeFrame': '1 year', 'description': 'comparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan'}, {'measure': 'Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire', 'timeFrame': '1 year', 'description': 'Improvement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan.'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor', 'timeFrame': '1 year', 'description': 'changes in the baseline of acute kidney injury, electrolyte imbalance and hemodynamic instability before and after taking treatment of sacubitril valsartan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronickindeydisease, qualityoflife'], 'conditions': ['Heart Failure NYHA Class IV', 'Heart Failure NYHA Class II']}, 'descriptionModule': {'briefSummary': "The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering", 'detailedDescription': 'Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '130 patients of heart failure with NYHA (II-IV)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with heart failure (NYHA class II-IV).\n2. LV EF(less than or equal to 40%).\n3. eGFR (more than 30 ml/min /1.73m2).\n\nExclusion Criteria:\n\n1. Symptomatic hypotension.\n2. eGFR\\<30 ml/min/1.73m2 .\n3. Serum potassium \\>5.2mmol/L\n4. Angioedema'}, 'identificationModule': {'nctId': 'NCT04218435', 'briefTitle': 'Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Clinision'}, 'officialTitle': 'Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'PK/IIS/001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Sacubitril/valsartan is a combination of a neprilysin inhibitor, sacubitril and an angiotensin II receptor blocker, valsartan.\n\nThe recommended starting dose is one 49/51 mg (sacubitril/valsartan) tablet twice-daily. Double the dose of Sacubitril/valsartan after 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient.\n\nReduce the starting dose to 24/26 mg (sacubitril/valsartan) twice-daily for:\n\n* Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.\n* Patients with severe renal impairment (CrCl less than 30 ml/min)\n* Patients with moderate hepatic impairment. (Child Pugh B) Double the dose of Sacubitril/valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient', 'interventionNames': ['Drug: Sacubitril / Valsartan Oral Tablet']}], 'interventions': [{'name': 'Sacubitril / Valsartan Oral Tablet', 'type': 'DRUG', 'otherNames': ['Sacvin'], 'description': 'Sacubitril/Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.\n\nSacubitril/Valsartan is usually administered in conjunction with another heart failure therapies, in place of an ACE inhibitor or other ARB.', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54590', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Doctors hospital and medical center', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Shahryar Shiekh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctors hospital and Medical center, Lahore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinision', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}