Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:56 AM
Study NCT ID:
NCT06023134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2023-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first event of adjudicated CV death mortality or adjudicated HHF', 'timeFrame': '24 weeks', 'description': 'The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated hospitalization for heart failure （HHF） in patients with right heart failure.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of adjudicated HHF (first and recurrent)', 'timeFrame': '24 weeks', 'description': 'any hospital admission due to HHF in 24 weeks'}, {'measure': 'Time to adjudicated CV death', 'timeFrame': '24 weeks', 'description': 'any CV death in 24 weeks'}, {'measure': 'Time to all-cause mortality', 'timeFrame': '24 weeks', 'description': 'any all-cause mortality in 24 weeks'}, {'measure': 'Time to first all-cause hospitalisation', 'timeFrame': '24 weeks', 'description': 'any hospital admission in 24 weeks'}, {'measure': 'Composite of time to first event of all-cause mortality and all cause hospitalisation', 'timeFrame': '24 weeks', 'description': 'The composite primary endpoint for this trial is the time to first event of all-cause mortality and all cause hospitalisation in patients with pulmonary hypertension'}, {'measure': 'Change in NYHA class from baseline at week 24', 'timeFrame': '24 weeks', 'description': 'Patients are assessed for NYHA class at each admission'}, {'measure': 'Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time', 'timeFrame': '24 weeks', 'description': 'Change from baseline to week 24 in N-terminal pro-brain natriuretic peptide (NT-proBNP).Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization'}, {'measure': 'Change in liver functions from baseline over time', 'timeFrame': '24 weeks', 'description': 'Change of transaminase or bilirubin from baseline to week 24 .Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization'}, {'measure': 'Change in renal function from baseline over time', 'timeFrame': '24 weeks', 'description': 'Change of estimated Glomerular Filtration Rate from baseline to week 24. The baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization'}, {'measure': 'Change in echocardiographic data from baseline over time', 'timeFrame': '24 weeks', 'description': 'Change from baseline to week 24 in echocardiographic data. Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization'}, {'measure': 'Change in ECG data from baseline over time', 'timeFrame': '24 weeks', 'description': 'Change from baseline to week 24 in ECG data.Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Right heart failure', 'Prognosis', 'Right ventricular function', 'Pulmonary hypertension', 'Biomarkers', 'diagnosis'], 'conditions': ['Right Heart Failure', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The study aims to describe the clinical characteristics and clarify the predictors of the short- and long-term outcomes of RHF patients, further assist the diagnosis, risk stratification and treatment of RHF.', 'detailedDescription': 'Right heart failure(RHF) is a clinical syndrome with symptoms, signs, and evidence of right ventricular systolic and/or diastolic dysfunction. For many years, it was largely neglected in the consideration of left-sided heart failure, while it is now evident that RHF is not only common but its presence also strongly contributes to increased morbidity and mortality. The in-hospital mortality of RHF is 7%, and the 30-day readmission rate is 20%. Therefore, diagnosis, potential treatment strategies, and prognosis improvement have become an unmet need in the field of cardiovascular disease.\n\nIn clinical practice, accurate diagnosis of RHF is the key to timely initiation of treatment and improvement of prognosis. Although current guidelines recommend clinical symptoms and signs combined with echocardiography, cardiac magnetic resonance, and other imaging means to evaluate right heart dysfunction for comprehensive diagnosis of right heart failure, the key diagnostic indicators included are inconsistent, the weight ratio of each indicator is different, the diagnostic threshold is not uniform, and the lack of comprehensive diagnostic model system brings great challenges to clinical practice.\n\nThis study aims to integrate multiple clinical biomarkers, imaging, and hemodynamic data to describe the clinical characteristics, establish noninvasive easy-to-use diagnosis models for right heart failure, and explore the risk factors for short- and long-term poor prognosis in patients with RHF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants who met the indications for right heart catheterization were monitored by hemodynamics and evaluated cardiac function by echocardiography. Those who met the diagnostic criteria for pulmonary hypertension were included in the pulmonary hypertension group, those who also met the diagnostic criteria for right heart failure were included in the right heart failure group, and the rest of the patients were included in the control group.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged ≥18 years at the time of consent\n2. Acceptation of right heart catheterization examination\n3. Able to perform the entire protocol\n\nExclusion Criteria:\n\n1. Life expectancy of less than 1 year based on the investigator's clinical judgment\n2. Pregnant or nursing\n3. Malignancy\n4. Planned to undergo heart transplantation or device implantation\n5. Acute coronary syndrome, uncontrolled severe arrhythmia and shock."}, 'identificationModule': {'nctId': 'NCT06023134', 'briefTitle': 'Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure', 'orgStudyIdInfo': {'id': 'PH-RHF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure.', 'interventionNames': ['Diagnostic Test: Echocardiography', 'Diagnostic Test: Right heart catheterization']}, {'label': 'Pulmonary Hypertension group', 'description': 'Participants were classified according to the 2022 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension, meaning that a mean pulmonary artery pressure (mPAP) ≥20 mmHg was defined as PH.', 'interventionNames': ['Diagnostic Test: Echocardiography', 'Diagnostic Test: Right heart catheterization']}, {'label': 'Right heart failure group', 'description': "Right heart failure was considered present when RV fractional area change (FAC) was \\<35% or tricuspid annular systolic velocity (RV S') was \\<9.5 cm/s or tricuspid annular plane systolic excursion (TAPSE) \\<17mm.", 'interventionNames': ['Diagnostic Test: Echocardiography', 'Diagnostic Test: Right heart catheterization']}], 'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Echocardiography will be used for specific right ventricular measurements or findings: TAPSE, TAPSE:PASP ratio, tissue Doppler velocity at lateral tricuspid annulus, fractional area change, right ventricular strain, right ventricular hypertrophy, right atrial size, volumes, ejection fraction, tricuspid and pulmonary regurgitation, inferior vena cava diameter and collapsibility, shift of interventricular septum, further assisting the diagnosis of RHF.', 'armGroupLabels': ['Control group', 'Pulmonary Hypertension group', 'Right heart failure group']}, {'name': 'Right heart catheterization', 'type': 'DIAGNOSTIC_TEST', 'description': 'Right heart catheterization is the "gold standard" for the diagnosis of PH. It also allows for direct measurement of intracardiac and pulmonary pressures, as well as cardiac output, and is commonly used to estimate right ventricular preload and afterload.', 'armGroupLabels': ['Control group', 'Pulmonary Hypertension group', 'Right heart failure group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jingyi Ren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jingyi Ren', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jingyi Ren', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}