Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-28 @ 2:35 AM
Study NCT ID:
NCT04894968
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of the Development of Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2021-05-17', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart failure with preserved ejection', 'timeFrame': 'At timepoint of inclusion', 'description': 'Presence of heart failure with preserved ejection fraction according to the European Society of Cardiology 2016 criteria'}], 'secondaryOutcomes': [{'measure': 'Occurence of major adverse cardiovascular events', 'timeFrame': '24-months after study inclusion', 'description': 'Patients will be followed-up after their inclusion in the PREDICT-HFpEF study for the occurence of major adverse cardiovascular events using regular telephone interviews.'}, {'measure': 'Changes in vascular status', 'timeFrame': 'At timepoint of inclusion', 'description': 'Patients vascular status will be screened at study inclusion (e.g. intima media thickness) and will be set in relation to initially assessed vascular status at their initial inclusion in the LIFE-Heart study'}, {'measure': 'Changes in organ function', 'timeFrame': 'At timepoint of inclusion', 'description': 'Patients liver, as well as renal function as assessed by laboratory status will be screened at study inclusion (e.g. creatinine, bilirubine, Gamma-glutamyltransferase) and will be set in relation to initially assessed vascular status at their initial inclusion in the LIFE-Heart study'}, {'measure': 'All-cause death', 'timeFrame': 'Yearly, after study enrollment up to ten years', 'description': 'Patients will be screened on a yearly basis for the occurence of all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure with preserved ejection fraction', 'Heart failure', 'Adiposity', 'Inflammation'], 'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '27081022', 'type': 'BACKGROUND', 'citation': 'Rommel KP, von Roeder M, Latuscynski K, Oberueck C, Blazek S, Fengler K, Besler C, Sandri M, Lucke C, Gutberlet M, Linke A, Schuler G, Lurz P. Extracellular Volume Fraction for Characterization of Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2016 Apr 19;67(15):1815-1825. doi: 10.1016/j.jacc.2016.02.018.'}, {'pmid': '29449367', 'type': 'BACKGROUND', 'citation': 'Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.'}]}, 'descriptionModule': {'briefSummary': 'The ultimate goal of the PREDICT-HFpEF study is to identify and unravel predictors for the development of heart failure with preserved ejection fraction (HFpEF) in a cohort at increased cardiovascular risk. Patients that were initially included in another prospective cohort study (LIFE-Heart study) and did not show evident heart failure at that timepoint, will be followed-up approximately 7-years after their initial inclusion in the LIFE-Heart study. Patients will be screened for the development of HFpEF and characterized with thorough clinical as well as laboratory assessment. Patients will be classified according to the presence of absence of heart failure and predictors for the development will be identified by using measurements taken at their initial inclusion in the LIFE-Heart study.', 'detailedDescription': 'Heart failure with preserved ejection fraction (HFpEF) is associated with severe morbidtiy and mortality. Yet, little is known about factors leading to the development of HFpEF investigated in a longitudinal fashion. The PREDICT-HFpEF study aims to adress this open question. Patients that were initially included in a large cohort study (LIFE-Heart study) approximately 7-years ago, that underwent thorough clinical, laboratory and echocardiographic assessment, and did not show evidence of heart failure at the present time point will be included in the current study.\n\nPatients will be screened for the development of HFpEF or other forms of heart failure (e.g. heart failure with reduced ejection fraction) and will again undergo thorough clinical, laboratory and echocardiographic assessment. Initially measured biomarkers (including clinical data, lab-charts, ECG recordings and echocardiography) will be used to predict the development of HFpEF in this cohort at cardiovascular risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients without evident heart failure with preserved ejection fraction that were included in the prospective cohort study: LIFE-Heart', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At timepoint of inclusion in the LIFE-Heart study normal left ventricular ejection fraction (≥ 50%)\n* At timepoint of inclusion in the LIFE-Heart study normal NT-proBNP (\\< 125 ng/l)\n\nExclusion Criteria:\n\n* At timepoint of inclusion in the LIFE-Heart study acute coronary syndrom\n\n 1. Troponine elevation above 14 pg/ml as well as coronary intervention, or isolated troponine elevation above 50 pg/ml in the absence of a coronary intervention\n 2. No troponine elevation but coronary intervention\n 3. Creatine kinase \\> 0.41 µmol/l\\*s and Creatine kinase to Creatine kinase-MB ration \\>6% or Creatine kinase-MB \\> 0.82 µmol/l\\*s\n* At timepoint of inclusion in the LIFE-Heart study missing data on left ventricular ejection fraction\n* At timepoint of inclusion in the LIFE-Heart study missing NT-proBNP measurement\n* At timepoint of inclusion in the LIFE-Heart study missing data on echocardiographic diastolic function and structural alterations of the left ventricle\n* At timepoint of inclusion in the LIFE-Heart study relevant valvular heart disease (including relevant aortic stenosis, mitral- and/or tricuspid regurgitation, congenital heart disease, mitral stenosis)'}, 'identificationModule': {'nctId': 'NCT04894968', 'acronym': 'PREDICT-HFpEF', 'briefTitle': 'Prediction of the Development of Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Heart Center Leipzig - University Hospital'}, 'officialTitle': 'Identifying Predictors for the Development and Uphold of Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'PREDICT-HFpEFv1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016', 'type': 'DIAGNOSTIC_TEST', 'description': "Patient will be screened for the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016.\n\nThis requires patients to fulfill all of the four criteria listed below:\n\n1. Symptoms of heart failure (e.g. dyspnea on extertion)\n2. Preserved ejection fraction (Left ventricular ejection fraction ≥50%\n3. NT-proBNP ≥125 pg/mL\n4. Echocardiographic signs for structural heart disease or diastolic dysfunction (at least one of the criteria below)\n\n * Left atrial volume index \\>34 mL/m²\n * Left ventricular mass index ≥115 g/m² for males or ≥95 g/m² for females\n * E/e' ≥13\n * Septal e' \\<9 cm/s"}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Lurz, MD, PhD', 'role': 'CONTACT', 'email': 'Philipp.Lurz@medizin.uni-leipzig.de', 'phone': '+49341865252022'}, {'name': 'Maximilian von Roeder, MD', 'role': 'CONTACT', 'email': 'maximilian.vonroeder@medizin.uni-leipzig.de', 'phone': '+49341865252517'}, {'name': 'Philipp Lurz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karl-Philipp Rommel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karl-Patrik Kresoja, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Heart Center Leipzig at Leipzig University', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Philipp Lurz, MD, PhD', 'role': 'CONTACT', 'email': 'philipp.lurz@medizin.uni-leipzig.de', 'phone': '0341865252022'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}