Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:29 AM
Study NCT ID:
NCT07341893
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2026-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacubitril-valsartan in Patients With Heart Failure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000319', 'term': 'Adrenergic beta-Antagonists'}], 'ancestors': [{'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2026-01-01', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE incidence', 'timeFrame': '3 months', 'description': 'Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death.'}, {'measure': 'Ejection fraction (EF%)', 'timeFrame': '3 months', 'description': 'Ejection fraction (EF%) improvement.'}], 'secondaryOutcomes': [{'measure': 'NT-proBNP level (pg/ml)', 'timeFrame': '3 months', 'description': 'Change in NT-proBNP level'}, {'measure': 'Galectin-3 level (pg/ml)', 'timeFrame': '3 months', 'description': 'Change in Galectin-3 level'}, {'measure': 'GDF-15 level (pg/ml)', 'timeFrame': '3 months', 'description': 'Change in GDF-15 level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NT-proBNP', 'Galectin 3', 'GDF-15', 'Sacubitril -Valsartan'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '39210725', 'type': 'BACKGROUND', 'citation': 'Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.'}, {'pmid': '33410280', 'type': 'BACKGROUND', 'citation': 'Lee YH, Lin PL, Chiou WR, Huang JL, Lin WY, Liao CT, Chung FP, Liang HW, Hsu CY, Chang HY. Combination of ivabradine and sacubitril/valsartan in patients with heart failure and reduced ejection fraction. ESC Heart Fail. 2021 Apr;8(2):1204-1215. doi: 10.1002/ehf2.13182. Epub 2021 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.', 'detailedDescription': '* A 3-month, prospective interventional study, which will include 60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.\n* Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. Patients will provided written informed consent and will be checked for inclusion and exclusion criteria.\n* All patients will undergo analysis of inflammatory biomarkers such as: NT-proBNP, Galectin-3 and GDF-15 at beginning of the study and after 3 months of the study.\n* Echocardiography study before and after the study focusing on:\n\nMeasurement of parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).\n\n\\- Follow up will be performed for assessing:\n\n1. MACE such as MI, stroke, HF, or death.\n2. LV Echocardiography improvements of any of basic Echo parameters.\n3. Assessment of New York Heart association (NYHA) class.\n\nOutcomes: all patients will be followed up for 3 months for:\n\n* 1ry outcomes: A.Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. B.Heart failure hospitalization C.LV Echocardiography improvements of any of basic Echo parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).\n* 2ry outcomes: Change in inflammatory markers such as: NT-proBNP, GDF-15 and Galectin-3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old for both genders.\n* LV ejection fraction (LVEF) ≤40%.\n* Heart failure patients with NYHA grade II-IV.\n\nExclusion Criteria:\n\n1. CKD with GFR \\< 20 ml/min/1.73\n2. Serum potassium \\< 5.5 mmol / L.\n3. Pregnant or lactating women\n4. Active infection.\n5. Congenital heart disease.\n6. Autoimmune disorders or connective tissue disorders.\n7. Severe hepatic dysfunction.'}, 'identificationModule': {'nctId': 'NCT07341893', 'briefTitle': 'Sacubitril-valsartan in Patients With Heart Failure.', 'organization': {'class': 'OTHER', 'fullName': 'Damanhour University'}, 'officialTitle': 'Clinical Study Evaluating Efficacy and Safety Sacubitril-valsartan in Patients With Heart Failure.', 'orgStudyIdInfo': {'id': 'sacubitril-valsartan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sacubitril-valsartan group', 'description': 'group (n=30) will be given Sacubitril-valsartan twice daily plus standard treatment.', 'interventionNames': ['Drug: Sacubitril-valsartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control group (n=30) on standard treatment of heart failure.', 'interventionNames': ['Drug: standard treatment of heart failure']}], 'interventions': [{'name': 'Sacubitril-valsartan', 'type': 'DRUG', 'otherNames': ['Entresto'], 'description': 'patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily.', 'armGroupLabels': ['Sacubitril-valsartan group']}, {'name': 'standard treatment of heart failure', 'type': 'DRUG', 'otherNames': ['Beta blockers, ACEis'], 'description': 'Control group (n=30) on standard treatment of heart failure.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Damanhūr', 'state': 'Elbehairah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rehab H Werida, Ass. Prof', 'role': 'CONTACT', 'email': 'rehabwrieda@pharm.dmu.edu.eg', 'phone': '01005359968'}, {'name': 'Nouran A. Abu Shaara, Bachlore', 'role': 'CONTACT', 'email': 'n.abushaara01529@pharm.dmu.edu.eg'}], 'facility': 'Damanhur Medical National Institute', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'centralContacts': [{'name': 'Rehab H Werida, Ass. Prof.', 'role': 'CONTACT', 'email': 'rehabwrieda@pharm.dmu.edu.eg', 'phone': '01005359968'}, {'name': 'Yasser E. Bahnacy, Ass. Prof.', 'role': 'CONTACT', 'email': 'yasserbahnacy@hotmail.com'}], 'overallOfficials': [{'name': 'Nouran A. Abu Shaara, Bachlore', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Damanhour University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rehab Werida', 'investigatorAffiliation': 'Damanhour University'}}}}