Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-24 @ 9:10 AM
Study NCT ID:
NCT01796093
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2012-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004077', 'term': 'Digoxin'}, {'id': 'D000077550', 'term': 'Ivabradine'}], 'ancestors': [{'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2012-09-05', 'studyFirstSubmitQcDate': '2013-02-19', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac function (diastolic and systolic function)', 'timeFrame': 'After 12-14 weeks', 'description': 'Cardiac function (echocardiography): systolic function (i.e. LVEF) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave.'}], 'secondaryOutcomes': [{'measure': 'Heart rate and blood pressure.', 'timeFrame': 'After 12-14 weeks', 'description': 'Changes in heart rate and blood pressure.'}, {'measure': 'Dyspnea.', 'timeFrame': 'After 12-14.weeks', 'description': 'Changes in dyspnea NYHA class).'}, {'measure': 'NB-proBNP value', 'timeFrame': 'After 12-14 weeks', 'description': 'Changes (serum values) after therapy.'}, {'measure': 'Body weight', 'timeFrame': '12-14. weeks', 'description': 'Changes after therapy'}, {'measure': 'Left atrial size', 'timeFrame': 'After 12-14 weeks', 'description': 'Change (size).'}, {'measure': 'ECG', 'timeFrame': 'After 12-14 weeks', 'description': 'Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias'}, {'measure': 'Laboratory', 'timeFrame': 'After 12-14 weeks', 'description': 'Any changes in hematology, electrolytes, renal and hepatic function.'}, {'measure': 'Side-effects', 'timeFrame': 'After 12-14 weeks', 'description': 'Any side-effects, spontaneously reported or after specific questionining.'}, {'measure': '6-min walk test', 'timeFrame': 'After 12-14 weeks.', 'description': 'Changes in length of the walk test and heart rate during the test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Digoxin', 'Ivabradine', 'Cardiac failure', 'Economics'], 'conditions': ['Heart Failure', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Cocco G, Jerie P. Comparison of digoxin and ivabradine in heart failure with preserved systolic function. Submitted to the American Heart Journal.'}]}, 'descriptionModule': {'briefSummary': 'This is an investigator-started study. The trial is coded as no. GC\\&PJ-Dig-Iva2009-2012.\n\nThe authors have no conflict of interest and there was no financial sponsoring The study was planned according to the Good Clinical Quality standards using an intention-to-treat analysis. The protocol was approved from the ethics committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the collected data and analysis. Analysis of collected data was performed by a single-blinded author (without knowledge of the used test drug and time of collection of data).\n\nStudy Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with permanent atrial fibrillation (ischemic etiology).\n\nMultiple Time Frames: Primary Outcome is measured before and after each medical intervention.\n\nMeasurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):\n\nMeasurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection rate, left trial size,diastolic function.\n\nParticipants were followed (ambulatory observation) for at least 3 months', 'detailedDescription': 'Selected patients had chronic coronary artery disease which had been treated with percutaneous dilatation \\& stenting and/or aortocoronary bypass. The severity of myocardial ischemia had induced heart failure with diastolic dysfunction and preserved systolic function, and permanent AF.\n\n1 Inclusion criteria:\n\nDyspnea class III NYHA.\n\nAbnormal left ventricular relaxation with preserved (≥52%) ejection fraction (LVEF).\n\nPatients either in sinus rhythm or with permanent atrial fibrillation.\n\n2\\. Exclusion criteria:\n\nUnstable angina pectoris.\n\nReduced systolic cardiac function (LVEF\\<52%).\n\nNormal diastolic function.\n\nDiabetes requiring insulin.\n\nModerate or severe renal or hepatic dysfunction.\n\nTechnically insufficient echocardiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic heart disease and heart failure with preserved systolic function, dyspnea grade III NYHA. Either in sinus rhythm (and possible paroxismal atrial fibrillation) or with permanent atrial fibrillation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNo need to change concomitant pharmacological therapy in the following months, dyspnea class III NYHA, and abnormal left ventricular relaxation with preserved (≥52%) left ventricular ejection fraction (LVEF).\n\nExclusion Criteria:\n\nUnstable myocardial ischemia, reduced systolic cardiac function (LVEF\\<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.'}, 'identificationModule': {'nctId': 'NCT01796093', 'acronym': 'DIGvsIVA', 'briefTitle': 'Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function', 'organization': {'class': 'INDIV', 'fullName': 'Cocco, Giuseppe, M.D.'}, 'officialTitle': 'Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.', 'orgStudyIdInfo': {'id': 'GC&PJ-Dig-Iva-2009-2012'}, 'secondaryIdInfos': [{'id': 'Cocco G, M.D.', 'type': 'OTHER_GRANT', 'domain': 'Cocco G, MD'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Digoxin cross-over ivabradine', 'description': 'Digoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg b.id. during 3 months.', 'interventionNames': ['Drug: Digoxin and ivabradine']}], 'interventions': [{'name': 'Digoxin and ivabradine', 'type': 'DRUG', 'otherNames': ['Medical therapy in heart failure with atrial fibrillation.', 'Drugs used: digoxin and ivabradine.'], 'description': 'No more details', 'armGroupLabels': ['Digoxin cross-over ivabradine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-4310', 'city': 'Rheinfelden', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Cardiology office', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}], 'overallOfficials': [{'name': 'Giuseppe Cocco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiologist, senior lecturer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cocco, Giuseppe, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Cardiology Office, Rheinfelden, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., FESC', 'investigatorFullName': 'Cocco G., M.D.', 'investigatorAffiliation': 'Cocco, Giuseppe, M.D.'}}}}