Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 9:40 PM
Study NCT ID:
NCT07326605
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-28
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac MRI-Derived Pressure-Volume Loop Analysis in Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5500}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2025-12-24', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with All-Cause Death', 'timeFrame': '3-year', 'description': 'All-cause death was defined as death from any cause occurring during the 3-year follow-up period. Mortality status was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Cardiovascular Death', 'timeFrame': '3-year', 'description': 'Cardiovascular death was defined as death resulting from cardiovascular causes occurring during the 3-year follow-up period. Cardiovascular causes included, but were not limited to, myocardial infarction, heart failure, fatal arrhythmia, stroke, or sudden cardiac death. The outcome was ascertained through review of medical records, hospital discharge summaries, and follow-up contacts.'}, {'measure': 'Number of Participants with Heart Failure Hospitalization', 'timeFrame': '3-year', 'description': 'Heart failure hospitalization was defined as any hospitalization for heart failure occurring during the 3-year follow-up period. Hospitalizations were identified based on hospital admission records with a primary diagnosis of heart failure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac MRI', 'Heart failure with preserved ejection fraction', 'Pressure loop analysis'], 'conditions': ['Heart Failure With Preserved Ejection Fraction (HFPEF)']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, observational study designed to evaluate the discriminative and prognostic value of pressure-volume (PV) loop analysis parameters and myocardial energetics derived from cardiac MRI in patients with heart failure with preserved ejection fraction (HFpEF). This study plans to enroll 3000 adult HFpEF patients and 500 adult healthy controls. The primary clinical endpoint was a composite of all-cause mortality and heart failure hospitalization, with events ascertained through medical records, clinic visits, and telephone follow-up. This study aims to determine whether cardiac MRI-derived PV loop analysis parameters and myocardial energetics provide incremental discriminative and prognostic information beyond conventional cardiac MRI parameters in patients with HFpEF. The study is non-interventional and does not involve any investigational drugs or devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heart failure with preserved ejection fraction experienced cardiac MRI scanning', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Symptoms and/or signs of HF ≥ New York Heart Association (NYHA) class II;\n2. Left ventricular ejection fraction (LVEF) of 50% or higher;\n3. N-terminal fragment of the prohormone of brain natriuretic peptide (NT-proBNP) level \\> 125 pg/mL or brain natriuretic peptide (BNP) level \\> 35 pg/mL in sinus rhythm, or NT-proBNP level \\> 365 pg/mL or BNP level \\> 105 pg/mL in atrial fibrillation;\n4. At least one of objective indicators of (i) cardiac structural abnormalities including LA maximum volume index (LAVi max) \\> 29 mL/m2 or echocardiography-measured LV end-diastolic mass index (LVMi) ≥ 115 g/m2 for men and ≥ 95 g/m2 for women, and (ii) LV diastolic dysfunction including early and/or late diastolic mitral inflow velocity (E/A) \\< 1 or early diastolic mitral inflow velocity and/or mitral annular peak early diastolic velocity (E/e') \\> 13.\n\nExclusion Criteria:\n\n1. Primary cardiomyopathy;\n2. Acute coronary syndrome;\n3. Primary severe valvular heart disease;\n4. Acute pulmonary embolism;\n5. Severe renal dysfunction;\n6. Poor image quality that was insufficient to identify myocardial endocardium and epicardium."}, 'identificationModule': {'nctId': 'NCT07326605', 'acronym': 'CMR-PV HFpEF', 'briefTitle': 'Cardiac MRI-Derived Pressure-Volume Loop Analysis in Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Discriminative and Prognostic Value of Myocardial Energetics and Pressure-Volume Loop Parameters Derived From Cardiac MRI in Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'CMR-PV HFpEF'}, 'secondaryIdInfos': [{'id': '82471973', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}, {'id': '7242110', 'type': 'OTHER_GRANT', 'domain': 'Beijing Natural Science Foundation'}, {'id': '3332025134', 'type': 'OTHER_GRANT', 'domain': 'Fundamental Research Funds for the Central Universities'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HFpEF patients', 'description': 'Heart failure with preserved ejection fraction (HFpEF) patients'}, {'label': 'Healthy controls', 'description': 'Sex- and age-matched healthy controls'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Minjie Lu', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}