Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01542502
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2012-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053590', 'term': 'Interleukin 1 Receptor Antagonist Protein'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aabbate@vcu.edu', 'phone': '804-828-0513', 'title': 'Antonio Abbate', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This is a pilot study to estimate the effects of targeted anti-inflammatory treatment on aerobic exercise capacity in patients with Heart Failure and Preserved Ejection Fraction. All findings should therefore be considered hypothesis generating.'}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Anakinra', 'description': 'Treatment with daily subcutaneous injections of Anakinra 100 mg\n\nAnakinra: Anakinra 100 mg daily subcutaneous injection', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Treatment with daily subcutaneous injection of placebo\n\nPlacebo: Placebo daily subcutaneous injection', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site reactions', 'notes': 'Mild injection site reaction - not requiring cessation of therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Oxygen Consumption (Peak VO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Treatment with daily subcutaneous injections of Anakinra 100 mg\n\nAnakinra: Anakinra 100 mg daily subcutaneous injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment with daily subcutaneous injection of placebo\n\nPlacebo: Placebo daily subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.3'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).', 'unitOfMeasure': 'ml*kg^-1*min^-1', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exercise Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anakinra', 'description': 'Treatment with daily subcutaneous injections of Anakinra\n\nAnakinra: Anakinra 100 mg daily subcutaneous injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Treatment with daily subcutaneous injection of placebo\n\nPlacebo: Placebo daily subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.05', 'upperLimit': '0.85'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.025', 'upperLimit': '0.925'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Correlation Between Endpoints', 'timeFrame': '28 days', 'description': 'Correlation between interval change in peak VO2 and high sensitivity C-reactive protein', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heart Failure Symptoms (DASI)', 'timeFrame': '28 days', 'description': 'Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events', 'timeFrame': '28 days', 'description': 'Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Biomarkers', 'timeFrame': '28 days', 'description': 'Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope)', 'timeFrame': '14 days', 'description': 'Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anakinra (First) Then Placebo (Second)', 'description': 'Treatment with daily subcutaneous injections of Anakinra 100 mg for 14 days, followed by daily subcutaneous injections of Placebo for 14 days\n\nAnakinra: Anakinra 100 mg daily subcutaneous injection Placebo: Placebo daily subcutaneous injection'}, {'id': 'FG001', 'title': 'Placebo (First) Then Anakinra (Second)', 'description': 'Treatment with daily subcutaneous injections of Placebo for 14 days, followed by daily subcutaneous injections of Anakinra for 14 days\n\nPlacebo: Placebo daily subcutaneous injection Anakinra: Anakinra 100 mg daily subcutaneous injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Baseline measures for all study participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This is a cross-over trial, so all patients have been treated with anakinra and with placebo at different times.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-12', 'studyFirstSubmitDate': '2012-02-23', 'resultsFirstSubmitDate': '2014-08-19', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-04', 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation Between Endpoints', 'timeFrame': '28 days', 'description': 'Correlation between interval change in peak VO2 and high sensitivity C-reactive protein'}, {'measure': 'Heart Failure Symptoms (DASI)', 'timeFrame': '28 days', 'description': 'Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.'}, {'measure': 'Adverse Events', 'timeFrame': '28 days', 'description': 'Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.'}, {'measure': 'Inflammatory Biomarkers', 'timeFrame': '28 days', 'description': 'Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.'}, {'measure': 'Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope)', 'timeFrame': '14 days', 'description': 'Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.'}], 'primaryOutcomes': [{'measure': 'Peak Oxygen Consumption (Peak VO2)', 'timeFrame': '14 days', 'description': 'The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).'}], 'secondaryOutcomes': [{'measure': 'Exercise Time', 'timeFrame': '14 days', 'description': 'Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure with preserved ejection fraction', 'Diastolic heart failure', 'Aerobic exercise performance'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptoms and signs of congestive heart failure\n* Recent Imaging Study (\\<12 months) showing Left Ventricular Ejection Fraction (LVEF) \\>50% and Left Ventricular End Diastolic Volume Index (LVEDVI) \\<97ml/m2\n* Evidence of abnormal Left Ventricular (LV) relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following:\n\n 1. Invasive Hemodynamic measurements\n\n * mean Pulmonary Capillary Wedge pressure (mPCW) \\>12\n * Left Ventricular End Diastolic Pressure (LVEDP) \\>16 mmHg\n 2. Tissue Doppler Echocardiogram\n\n * E/E' \\>15\n * E/E' 8-15 and one of the following\n\n * Left Ventricular Hypertrophy (LVH)\n * Atrial Fibrillation\n * Left Atrial Enlargement\n * E/A \\<0.5 + Deceleration Time (DT) \\>280 (if \\>50yrs of age)\n 3. Biomarkers\n* Brain Natriuretic Peptide (BNP) \\>200pg/mL\n\nExclusion Criteria:\n\n* Age \\<18\n* Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme \\[ACE\\] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)\n* Hospitalization for worsening Heart Failure (HF) or acute decompensated HF within the previous 12months\n* Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD)\n* Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing\n* Active infection including chronic infection\n* Active cancer\n* Recent (\\<14 days) use of anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs \\[NSAIDs\\]), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study\n* Pregnancy (determined by urine pregnancy test in women of childbearing potential)\n* Inability to give informed consent\n* Other conditions limiting completion of cardiopulmonary exercise test or completion of the study"}, 'identificationModule': {'nctId': 'NCT01542502', 'briefTitle': 'Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'HM14079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anakinra', 'description': 'Treatment with daily subcutaneous injections of Anakinra 100 mg', 'interventionNames': ['Drug: Anakinra']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Treatment with daily subcutaneous injection of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Anakinra', 'type': 'DRUG', 'otherNames': ['Recombinant human Interleukin-1 receptor antagonist', 'Kineret'], 'description': 'Anakinra 100 mg daily subcutaneous injection', 'armGroupLabels': ['Anakinra']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sodium Chloride (NaCl) 0.9%'], 'description': 'Placebo daily subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Antonio Abbate, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}