Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-29 @ 9:12 PM
Study NCT ID:
NCT06991257
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
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': 'D003276', 'term': 'Contraceptives, Oral'}], 'ancestors': [{'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind, placebo-controlled study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 620}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Clinical Events', 'timeFrame': 'over 36 weeks', 'description': 'Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.'}, {'measure': 'Change From Baseline in 6-Minute Walk Test (6MWD)', 'timeFrame': 'Baseline, week 36 post-dose', 'description': 'A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.'}, {'measure': 'Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS)', 'timeFrame': 'Baseline, week 36', 'description': 'KCCQ is a 23-item heart-failure specific questionnaire quantified into the following scores: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy, total symptom score, overall summary score, and clinical summary score. To facilitate interpretation, all scores are presented on a scale of 0 to 100 points, with lower scores indicating more severe symptoms and/or limitations, and a score of 100 indicating no symptoms, no limitations, and excellent quality of life.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Baseline, up to week 40', 'description': 'An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE that, at any dose, results in 1 or more of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.'}, {'measure': 'Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Symptom Score (KCCQ-23 TSS) and physical limitation in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.', 'timeFrame': 'Baseline, week 36', 'description': 'KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). Two summary scores are also calculated: Clinical Summary (calculated as mean of Physical limitation and Total symptom scores) and Overall Summary (calculated as mean of Physical limitation, Social limitation, Total symptoms, and Quality of life scores). Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status.'}, {'measure': 'Change From Baseline in 6-minute walk test distance (6MWD) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.', 'timeFrame': 'Baseline, week 36', 'description': 'A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.'}, {'measure': 'CPET Substudy) : Change From Baseline in Peak Oxygen Consumption (pVO2) at Week 36', 'timeFrame': 'Baseline, Week 36', 'description': 'Cardiopulmonary exercise testing'}, {'measure': 'Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36', 'timeFrame': 'Baseline, Week 36', 'description': 'NT-proBNP is a biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).'}, {'measure': 'Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall clinical symptom Score (KCCQ-23 CSS) and physical limitation) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.', 'timeFrame': 'Baseline, week 36', 'description': 'KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). Two summary scores are also calculated: Clinical Summary (calculated as mean of Physical limitation and Total symptom scores) and Overall Summary (calculated as mean of Physical limitation, social limitation, Total symptoms, and Quality of life scores). Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure with mildly reduced ejection', 'Heart Failure with preserved ejection fraction'], 'conditions': ['Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4921003', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF).', 'detailedDescription': 'All participants in this study will take either the study medicine (PF-07328948) tablets, or placebo tablets, once daily, by mouth, every day for 36 weeks. The study determines if the study medicine (PF-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard-of-care medications for heart failure that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants will be involved in this study for about 48 weeks. During this time, participants will visit the study clinic 15 times. In general, 5 of these visits may be performed at home by phone and the other 10 visits will take place at the study site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'This study is seeking participants who are:\n\nKey Inclusion Criteria include:\n\n* aged 18 years or older.\n* \\- clinically confirmed to have a diagnosis of heart failure for at least 3 months\n* New York Heart Association Class II-IV symptoms\n* left ventricular ejection fraction greater than 40%\n* Body mass index of 27 kg/m2 or higher\n* Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score \\< 85\n* Six-minute walking distance greater than 75 meters\n\nKey Exclusion Criteria include:\n\n* Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.\n* Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor.\n* History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes\n* Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor'}, 'identificationModule': {'nctId': 'NCT06991257', 'briefTitle': 'A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN ORAL BRANCHED-CHAIN KETOACID DEHYDROGENASE KINASE INHIBITOR, PF-07328948, IN ADULTS WITH HEART FAILURE (BRANCH-HF)', 'orgStudyIdInfo': {'id': 'C4921003'}, 'secondaryIdInfos': [{'id': '2024-518438-94-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ARM 1', 'description': 'Placebo Participants will receive Placebo for up to 36 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 2', 'description': 'Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks', 'interventionNames': ['Drug: Low Dose PF-07328948']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 3', 'description': 'Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks', 'interventionNames': ['Drug: Medium Dose PF-07328948']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 4', 'description': 'High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks', 'interventionNames': ['Drug: High Dose PF-07328948']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'ARM 1', 'armGroupLabels': ['ARM 1']}, {'name': 'Low Dose PF-07328948', 'type': 'DRUG', 'otherNames': ['low dose'], 'description': 'ARM 2', 'armGroupLabels': ['ARM 2']}, {'name': 'Medium Dose PF-07328948', 'type': 'DRUG', 'otherNames': ['medium dose'], 'description': 'ARM 3', 'armGroupLabels': ['ARM 3']}, {'name': 'High Dose PF-07328948', 'type': 'DRUG', 'otherNames': ['High dose'], 'description': 'ARM 4', 'armGroupLabels': ['ARM 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'National Heart Institute', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'FWD Clinical Research', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33169', 'city': 'North Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Amavita Research Services', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '60429', 'city': 'Hazel Crest', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Chicago Medical Research', 'geoPoint': {'lat': 41.5717, 'lon': -87.69449}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Velocity Clinical Research, Lincoln, Pioneer Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '78526', 'city': 'Brownsville', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Headlands Horizons, LLC dba Headlands Research-Brownsville', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '78526', 'city': 'Brownsville', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Valley Regional Medical Center', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '75069', 'city': 'McKinney', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'North Dallas Research Associates', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwest Houston Heart Center', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': 'G9A 4P3', 'city': 'Trois-Rivières', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Diex Recherche Trois-Rivieres', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': '486-8510', 'city': 'Kasugai', 'state': 'Aichi-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Kasugai Municipal Hospital', 'geoPoint': {'lat': 35.24762, 'lon': 136.97229}}, {'zip': '271-0077', 'city': 'Matsudo', 'state': 'Chiba', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Seikeikai New Tokyo Heart Clinic', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '252-5188', 'city': 'Sagamihara', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sagamihara Kyodo Hospital', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '221-0855', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': "Yokohama Municipal Citizen's Hospital", 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '245-8575', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Yokohama Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '514-1101', 'city': 'Tsu', 'state': 'Mie-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Mie Chuo Medical Center', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '983-8520', 'city': 'Sendai', 'state': 'Miyagi', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Sendai Medical Center', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '351-0102', 'city': 'Wako', 'state': 'Saitama', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Saitama Hospital', 'geoPoint': {'lat': 35.78944, 'lon': 139.62333}}, {'zip': '152-8902', 'city': 'Meguro-Ku', 'state': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Tokyo Medical Center'}, {'zip': '006-0811', 'city': 'Sapporo', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Teine Keijinkai Hospital'}, {'zip': '168-0065', 'city': 'Suginami', 'state': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'NewHeart Watanabe Institute'}, {'zip': '171-0014', 'city': 'Toshimaku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Sekino Hospital'}, {'zip': '740-8510', 'city': 'Iwakuni', 'state': 'Yamaguchi', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Iwakuni Clinical Center', 'geoPoint': {'lat': 34.16297, 'lon': 132.22}}], 'centralContacts': [{'name': 'Pfizer CT.gov Call Center', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}