Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT03437369
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077550', 'term': 'Ivabradine'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in pulmonary wedge pressure and cardiac output after 24h-treatment with ivabradine or standard of care treatment.', 'timeFrame': '24 hours', 'description': 'Reduction of pulmonary wedge pressure from baseline in both treatment arms (ivabradine arm versus standard of care treatment measured by Swan Ganz balloon flotation catheter)'}], 'secondaryOutcomes': [{'measure': 'Severe bradycardia', 'timeFrame': '24 hours', 'description': '-Development of excessive bradycardia defined as heart rate (HR) \\<50 beats per minute'}, {'measure': 'Arrhythmias', 'timeFrame': '24 hours', 'description': 'New-onset of ventricular arrhythmias or atrial fibrillation'}, {'measure': 'Hypotension', 'timeFrame': '24 hours', 'description': 'Hypotension, defined as systolic blood pressure \\<90 mmHg'}, {'measure': 'Time to withdrawal of vasoactive drugs', 'timeFrame': '30 days', 'description': '-Time to catecholamine withdrawal in both treatment arms (days)'}, {'measure': 'Time needing invasive mechanical ventilation', 'timeFrame': '30 days', 'description': 'Mechanical (invasive) ventilation time after initiation of ivabradine/control treatment.'}, {'measure': 'B-type natriuretic peptide (BNP)', 'timeFrame': '30 days', 'description': 'Measured B-type natriuretic peptide (BNP) values at 30 days'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': '30 days', 'description': 'Change in left ventricle ejection fraction from baseline in both treatment arms (%)'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '30 days', 'description': 'Mortality due to cardiovascular causes'}, {'measure': 'Total mortality', 'timeFrame': '30 days', 'description': 'Mortality from any cause'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ivabradine, heart rate, acute heart failure'], 'conditions': ['Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '16214830', 'type': 'BACKGROUND', 'citation': 'Tardif JC, Ford I, Tendera M, Bourassa MG, Fox K; INITIATIVE Investigators. Efficacy of ivabradine, a new selective I(f) inhibitor, compared with atenolol in patients with chronic stable angina. Eur Heart J. 2005 Dec;26(23):2529-36. doi: 10.1093/eurheartj/ehi586. Epub 2005 Oct 7.'}, {'pmid': '20801500', 'type': 'BACKGROUND', 'citation': 'Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1.'}, {'pmid': '19944362', 'type': 'BACKGROUND', 'citation': 'Fasullo S, Cannizzaro S, Maringhini G, Ganci F, Giambanco F, Vitale G, Pinto V, Migliore G, Torres D, Sarullo FM, Paterna S, Di Pasquale P. Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings. J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3.'}, {'pmid': '11245648', 'type': 'BACKGROUND', 'citation': 'Lechat P, Hulot JS, Escolano S, Mallet A, Leizorovicz A, Werhlen-Grandjean M, Pochmalicki G, Dargie H. Heart rate and cardiac rhythm relationships with bisoprolol benefit in chronic heart failure in CIBIS II Trial. Circulation. 2001 Mar 13;103(10):1428-33. doi: 10.1161/01.cir.103.10.1428.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized 1:1 blinded study that evaluate in acute left heart failure-cardiogenic shock patients if ivabradine treatment can reduce pulmonary wedge pressure, without inducing a significant or relevant reduction in cardiac output or increasing the risk of arterial hypotension and with the benefit of allowing a faster titration of heart failure drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged ≥ 18 years, with acute heart failure due to left ventricular systolic dysfunction (LVEF ≤ 40%) in sinus rhythm, baseline HR ≥ 90 bpm, with signs of low peripheral perfusion with indication for intravenous inotropic treatment (catecholamines: dobutamine , adrenaline, dopamine or noradrenaline) and admitted to the Cardiological Intensive Care Unit.\n* Pharmacological treatment and stable hemodynamic situation in the 4 hours before inclusion.\n* Pulmonary wedge pressure ≥ 18 mm Hg and systolic blood pressure \\> 90 mm Hg.\n* Patient's signature on the consent form.\n\nExclusion Criteria:\n\n* Previous treatment with ivabradine (\\< 48 hours).\n* Known hypersensitivity to ivabradine.\n* Cardiac rhythm different from sinus rhythm.\n* Unstable cardiac rhythm due to paroxysmal atrial fibrillation or atrial flutter, very frequent ventricular or supraventricular premature beats, ventricular tachycardia, 2nd or 3rd degree atrioventricular (AV) block.\n* Severe chronic renal failure (estimated glomerular filtration rate ≤15 ml / min) or on chronic treatment with dialysis.\n* QT interval higher than 450 ms.\n* Sepsis as a probable mechanism of tachycardia and hypotension.\n* Need for urgent cardiac surgery, planned within 72 hours of possible inclusion.\n* Severe aortic stenosis or severe valvular disease that requires surgical correction.\n* Patient must not have received an IV bolus of furosemide immediately before the baseline hemodynamic assessment.\n* Severe hepatic insufficiency.\n* Patient must not be participating in another clinical trial.\n* Concomitant use of potent CYP3A4 inhibitors.\n* Acute anemia or hypovolemia uncorrected.\n* Pregnancy."}, 'identificationModule': {'nctId': 'NCT03437369', 'acronym': 'ES-FISH', 'briefTitle': 'Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Efficacy and Safety on Heart Rate Control With Ivabradine on Cardiogenic Shock (ES-FISH)', 'orgStudyIdInfo': {'id': 'HURamonyCajal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivabradine', 'description': 'Drug: Ivabradine Oral tablets 2.5 mg Dose: 10-15 mg/day Duration: 30 days', 'interventionNames': ['Drug: Ivabradine Oral Tablet']}, {'type': 'OTHER', 'label': 'Standard of Care', 'description': 'The study drug will be compared with standard of Care treatment', 'interventionNames': ['Other: Standard of Care treatment']}], 'interventions': [{'name': 'Ivabradine Oral Tablet', 'type': 'DRUG', 'description': 'The target dose is 10 to 15 mg / day, administered orally in two doses', 'armGroupLabels': ['Ivabradine']}, {'name': 'Standard of Care treatment', 'type': 'OTHER', 'description': 'The study drug will be compared with the standard of Care treatment', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Marcelo Sanmartin, MD', 'role': 'CONTACT', 'email': 'msanfer@me.com', 'phone': '+34 91 336 80 00'}, {'name': 'Marina Pascual Izco, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luis Miguel Rincón Díaz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gonzalo Luis Alonso Salinas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manuel Jimenez Mena, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Asunción Camino González, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jose Luis Zamorano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcelo Sanmartín Fernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Marcelo Sanmartín Fernández, PhD', 'role': 'CONTACT', 'email': 'msanfer@me.com', 'phone': '+34 91 336 80 00'}], 'overallOfficials': [{'name': 'Marcelo Sanmartín Fernández, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramon y Cajal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Acute Coronary Syndrome Process', 'investigatorFullName': 'Marcelo Sanmartín Fernández', 'investigatorAffiliation': 'Hospital Universitario Ramon y Cajal'}}}}