Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04688905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2020-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017023', 'term': 'Coronary Angiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D006334', 'term': 'Heart Function Tests'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Approximately 40 ml of blood will be drawn for the conduction of hemogram, sodium, potassium, creatine, eGFR, urea, coagulation, TSH, CK, high-sensitivity troponin T, NT-proBNP, HbA1c, lipids, iron status as well as biobanking (at -80°C) for 15 years.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HFpEF-positive patients', 'timeFrame': 'Within one day', 'description': 'Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction'}], 'secondaryOutcomes': [{'measure': 'H2FPEF score', 'timeFrame': 'Within two days', 'description': "Difference in H2FPEF score in patients with approved and excluded HFpEF (BMI \\> 30 kg/m²: 2 points, 2 or more antihypertensive medicines: 1 point, atrial fibrillation: 3 points, pulmonary hypertension: 1 point, age \\> 60 years: 1 point, E/E' \\> 9: 1 point. Sum: 0-9 points with rising probability of HFpEF with increasing score)"}, {'measure': 'HFA-PEFF score', 'timeFrame': 'Within two days', 'description': 'Difference in HFA-PEFF score in patients with approved and excluded HFpEF (0-2 points regarding functional, morpholigical and biomarker parameters. Sum: 0-6 points; 0-1 points:exclusion of HFpEF, 2-5 points: further diagnostic (stress test or invasive) required, 5-6 points: HFpEF diagnosed.'}, {'measure': 'Difference in DPVQ (echocardiographic)', 'timeFrame': 'Within two days', 'description': 'Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF'}, {'measure': "Difference in E/E' (echocardiographic)", 'timeFrame': 'Within two days', 'description': "E/E' (at rest and under exertion) in patients with approved and excluded HFpEF"}, {'measure': 'Difference in GLS (echocardiographic)', 'timeFrame': 'Within two days', 'description': 'Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF'}, {'measure': 'Difference in MRI parameters', 'timeFrame': 'Within two days', 'description': 'Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF'}, {'measure': 'Difference in pulmonary artery pressure (right heart catheter)', 'timeFrame': 'Within two days', 'description': 'Pulmonary artery pressure at rest and under exertion in patients with approved and excluded HFpEF'}, {'measure': 'Difference in wedge pressure (right heart catheter)', 'timeFrame': 'Within two days', 'description': 'Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF'}, {'measure': 'Difference in DPVQ (echocardiographic) after one year', 'timeFrame': '1 year', 'description': 'Diastolic pressure-volume quotient (DPVQ) at rest in patients with approved and excluded HFpEF after one year'}, {'measure': "Difference in E/E' (echocardiographic) after one year", 'timeFrame': '1 year', 'description': "E/E' at rest in patients with approved and excluded HFpEF after one year"}, {'measure': 'Difference in GLS (echocardiographic) after one year', 'timeFrame': '1 year', 'description': 'Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyspnea']}, 'referencesModule': {'references': [{'pmid': '41233022', 'type': 'RESULT', 'citation': 'Gessner R, Hubner AC, Stobe S, Rudolph UM, Unger L, Schmeisser A, Steendijk P, Uhe T, Stegmann T, Lavall D, Hagendorff A, Laufs U, Wachter R. Diagnosing HFpEF in Patients With Unexplained Dyspnea by Using Invasive Left Ventricular Pressure-Volume Loops. J Card Fail. 2025 Nov;31(11):1661-1671. doi: 10.1016/j.cardfail.2025.09.010.'}]}, 'descriptionModule': {'briefSummary': 'Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools', 'detailedDescription': 'Multiple diagnostic tests, including stress tests and the invasive conduction of left ventricular pressure-volume loops via conductance catheter (as gold standard) will be performed in patients with unexplained dyspnea NYHA II-III in order to identify patients with a heart failure with preserved ejection fraction (HFpEF). The results will be compared to previously reported diagnostic scores such as the H2FPEF and the HFA-PEFF score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with unexplained dyspnea NYHA II-III', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dyspnea NYHA II-III\n* age 18-90 years\n* left ventricular ejection fraction ≥ 50%\n* ability to give informed consent\n\nExclusion Criteria:\n\n* unstable cardiac disease with acute decompensation\n* documented former LVEF ≤ 40%\n* heart valve disease with medium or high grade insufficiency or stenosis\n* coronary heart disease with hemodynamically relevant coronary stenosis\n* specific cardiomyopathia\n* acute or chronic cardiac inflammation (myocarditis, pericarditis)\n* former heart transplantation\n* relevant pulmonary disease (e.g. COPD) assumably causing the dyspnea\n* FEV1/VC \\< 70%\n* hemoglobin \\< 5 mmol/l\n* pregnant or nursing women\n* contraindication for one of the diagnostic tests'}, 'identificationModule': {'nctId': 'NCT04688905', 'briefTitle': 'Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)', 'orgStudyIdInfo': {'id': '283/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dyspnea explained by heart failure with preserved ejection fraction', 'description': 'All patients fulfilling invasive criteria for heart failure with preserved ejection fraction', 'interventionNames': ['Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion']}, {'label': 'Dyspnea not explained by heart failure with preserved ejection fraction', 'description': 'All patients not fulfilling invasive criteria for heart failure with preserved ejection fraction', 'interventionNames': ['Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion']}], 'interventions': [{'name': 'Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Cardiac MRI at rest', 'Echocardiography at rest and with exercise', 'Spiroergometry', '6 minute walking distance', 'Right heart catherization at rest and with exercise', 'Coronary angiography (if not performed within the last year)'], 'description': 'Invasive hemodynamics of left ventricle will be done by the conductance method. Left ventricular stiffness constant will be obtained by temporary vena cava occlusion. Right heart catherization will be done by pulmonary artery catherization and cardiac output will be estimated by thermodilution and Fick´s method.', 'armGroupLabels': ['Dyspnea explained by heart failure with preserved ejection fraction', 'Dyspnea not explained by heart failure with preserved ejection fraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Available upon reasonable scientific request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rolf Wachter', 'investigatorAffiliation': 'University of Leipzig'}}}}