Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT04688294
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2020-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-18', 'studyFirstSubmitDate': '2020-12-19', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in NTproBNP plasma concentration', 'timeFrame': 'at baseline', 'description': 'NTproBNP is a Biomarker used to assess severity of congestive heart failure)'}, {'measure': 'change in NTproBNP plasma concentration', 'timeFrame': 'at 6 months', 'description': 'NTproBNP is a Biomarker used to assess severity of congestive heart failure)'}, {'measure': 'severity of congestive heart failure.', 'timeFrame': 'at baseline', 'description': 'Ejection fraction'}, {'measure': 'severity of congestive heart failure.', 'timeFrame': 'at 6 months', 'description': 'Ejection fraction'}], 'secondaryOutcomes': [{'measure': 'change in plasma potassium concentration', 'timeFrame': 'every month, up to 6 months', 'description': 'plasma potassium (intracellular cation) concentration used to evaluate Sacubitril-Valsartan'}, {'measure': 'change in serum sodium concentration', 'timeFrame': 'every month, up to 6 months', 'description': 'serum sodium (extracellular cation) concentration used to evaluate Sacubitril-Valsartan'}, {'measure': 'change in serum creatinine', 'timeFrame': 'every month, up to 6 months', 'description': 'serum creatinine which is a byproduct of muscle protein metabolism is used to evaluate Sacubitril-Valsartan'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan combination in treatment of patients with Congestive heart failure. Moreover, the investigators aim to evaluate side effects of this combination.\n\n\\- The following parameters were determined at baseline and at end of the study at 6 months of the beginning.\n\n1. New York Heart Association (NYHA) Class.\n2. Frequency of hospitalization by acute exacerbation of CHF\n3. NT-ProBNP\n4. Left ventricular systolic function by Echocardiography\n\nMoreover, the side effects of the drugs used during study was assessed by\n\n1. Renal function (Serum creatinine) was performed every month till the end of the study.\n2. Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 40 - 60 years\n2. Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification\n3. Left Ventricular Ejection Fraction of 40% or less.\n4. NT-proBNP level of at least ≥400 pg per milliliter\n5. ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day.\n\nExclusion Criteria:\n\n1. Patients with symptomatic hypotension.\n2. Pregnant and nursing women\n3. Systolic blood pressure \\< 100 mmHg at screening or \\< 95 mmHg at randomization\n4. Patients with glomerular filtration rate \\<30 mL/min/1.73 m2\n5. Patients with history of angioedema\n6. Patients with unacceptable side effects with ACE-inhibitors or ARBs.'}, 'identificationModule': {'nctId': 'NCT04688294', 'briefTitle': 'The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': '3/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sacubitril/valsartan', 'description': 'Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy.', 'interventionNames': ['Drug: Sacubitril-Valsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valsartan', 'description': 'Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.', 'interventionNames': ['Drug: Valsartan']}], 'interventions': [{'name': 'Sacubitril-Valsartan', 'type': 'DRUG', 'description': '30 patients initially received Sacubitril/Valsartan at 24/26 mg twice daily orally then dose was doubled as tolerated every 2-4 weeks to reach the target maintenance dose 97 mg/103 mg twice daily', 'armGroupLabels': ['Sacubitril/valsartan']}, {'name': 'Valsartan', 'type': 'DRUG', 'description': '30 patients received valsartan, starting at a dose of 40 mg/day orally. The dose was then doubled every 1-2 weeks on the basis of their blood pressure to reach a dose of 160 mg once daily according to guideline-directed medical therapy.', 'armGroupLabels': ['Valsartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Wadi El-Neel Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amir Safwat', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant', 'investigatorFullName': 'Amir Safwat', 'investigatorAffiliation': 'Suez Canal University'}}}}