Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-27 @ 5:51 PM
Study NCT ID:
NCT04154657
Status:
UNKNOWN
Last Update Posted:
2020-07-28
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single cohort observational pathophysiologic study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delta Eed', 'timeFrame': 'immediate after procedure', 'description': 'RV stiffness measured by conductance catheter is reduced alreday in early HFpEF stages'}, {'measure': 'delta RV volume', 'timeFrame': 'immediate after procedure', 'description': 'homeometric followed by teterometric adaptation with consecutive dilation of the RV occurs with disease progression from HFpEF-Non-PH ti ICC-PH\\_HFpEF to cpc-PH-HFpEFprogressive H, impacting position and motion of the septum with stress'}], 'secondaryOutcomes': [{'measure': 'correlation of delta RV longitudinal strain with Eed', 'timeFrame': 'immediate after procedure', 'description': 'RV longitudinal strain (related to RV EDV) is the best predictor of RV diastolic stiffness (Eed) in HFpEF-PH (correlation analysis)'}, {'measure': 'delta transmural septal pressure', 'timeFrame': 'immediate after procedure', 'description': 'acute change of the transmural pressure gradients from rest to stress conditions, adversly impacts LV filling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFpEF', 'pulmonary hypertension'], 'conditions': ['Heart Failure, Diastolic']}, 'descriptionModule': {'briefSummary': 'Biventricular PV-loop studies and advanced imaging to assess left-to-right ventricular interaction in HFpEF: In a group of 30 HFpEF patients with clinical indication for LH/RH catheter investigation, we will perform biventricular PV loop assessment in combination with extensive imaging (MRI, echo) for in-depth analysis of left-to-right ventricular interaction in the different HFpEF categories, both under baseline and stress (volume challenge and exercise) conditions.', 'detailedDescription': 'The right ventricle is the main determinant of prognosis in pulmonary hypertension . The response of the right ventricle to the structural alterations and increasing afterload in the pulmonary circulation is a complex process. The interplay between neuroendocrine and paracrine signalling and increased afterload may lead to myocardial ischemia and inflammation, resulting in loss of myocytes, myocardial fibrosis and RV-arterial uncoupling. Pulmonary hypertension in the setting of heart failure with preserved ejection fraction (HFpEF-PH) is a frequent complication which is associated with impaired prognosis. HFpEF-PH is defined by a high mean pulmonary artery pressure (\\> 20 mm Hg), high left ventricular end-diastolic pressure (LVEDP \\> 15 mm Hg) and a normal systolic left ventricular function with impaired diastolic function. However, not all HFpEF patients develop pulmonary vascular remodelling with a high transpulmonary pressure gradient, and increased pulmonary vascular resistance leading to adverse right ventricular remodelling. Ageing, increased left atrial pressure and stiffness, mitral regurgitation, as well as features of metabolic syndrome, including obesity, diabetes and hypertension, are recognized as clinical risk factors for HFpEF-PH. A main and emerging question in that context is the interplay between the right and left ventricle in HFpEF-PH, and whether diastolic left ventricular failure is the driving force of the hemodynamic and right ventricular functional changes. Recent studies have shown that HFpEF-PH patients demonstrate haemodynamic limitations during exercise, including impaired recruitment of LV preload due to excessive right heart congestion and blunted RV systolic reserve compared to HFpEF without PH . However, up to now, no data exist about the mechanism of interplay between RV, LV and pulmonary haemodynamics in HFpEF and HFpEF-PH. Whereas in patients with HFpEF, PV loop analysis has demonstrated that increased end-diastolic pressure at rest is associated with higher end-diastolic stiffness, and a consistently upwards and leftwards shifted pressure volume relationship during exercise and volume challenge, Gortner et al suggest that reduced LV preload (measured by LV transmural pressure gradient) due to excessive RV congestion, is a major driver for reduced cardiac output in HFpEF-PH. However, preliminary own data in 21 patients with HFpEF demonstrate a more complex relationship with approximately one third of patients not showing an increase of (RV and LV ) end-diastolic pressure volume relation during exercise.\n\nThus, a simultaneous PV loop-catheterization of LV and RV, in addition to right heart catheter, would therefore provide an enormous gain of knowledge about the interaction of RV and LV and would contribute to a better understanding of the pathophysiology of HFpEF-PH and HFpEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nDiagnosis of HFpEF as follows\n\n* Heart failure NYHA II or NYHA III\n* LVEF ≥ 50%\n* HFA-PEFF score ≥ 5 OR HFA-PEFF score 2-4 with one of the following criteria:\n* baseline PCWP ≥ 15 mm Hg OR PCWP increase ≥ 10 mm Hg with exercise (\\~20 Watt)\n* stable medical therapy for last 4 weeks\n\nExclusion criteria:\n\n* Significant coronary stenosis \\> 50% or valvular heart disease requiring intervention\n* coronary or cardiac valvular intervention \\< 3 months\n* uncontrolled rate of atrial fibrillation\n* Severe chronic kidney disease (MDRD eGFR \\< 30 ml/min)\n* Life expectancy \\< 12 months\n* Contraindication to MRI or other planned investigations'}, 'identificationModule': {'nctId': 'NCT04154657', 'acronym': 'INTERACT-HFpEF', 'briefTitle': 'Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Disclosing Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction With and Without Pulmonary Hypertension - Insights From Invasive Hemodynamic and Imaging', 'orgStudyIdInfo': {'id': 'Interact_HFpEF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'biventricular conductance catheter', 'description': 'patients with indication for invasive assessment receive right and left heart catheter and parallel biventricular conductance catheter at rest and stress', 'interventionNames': ['Procedure: conductance catheter measurement']}], 'interventions': [{'name': 'conductance catheter measurement', 'type': 'PROCEDURE', 'otherNames': ['pressure volume loop catheter measurement'], 'description': 'biventricular parallel conductance catheter measurement at rest and stress conditions, + CMR at rest and stress', 'armGroupLabels': ['biventricular conductance catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Eike Nagel, MD', 'role': 'CONTACT', 'email': 'eike.nagel@kgu.de', 'phone': '+49696301', 'phoneExt': '84491'}, {'name': 'Valentina M Puntmann, MD', 'role': 'CONTACT', 'email': 'valentina.puntmann@kgu.de', 'phone': '+49696301', 'phoneExt': '84491'}], 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '35392', 'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Birgit Assmus, MD', 'role': 'CONTACT', 'email': 'birgit.assmus@innere.med.uni-giessen.de', 'phone': '+49 641 985', 'phoneExt': '42637'}, {'name': 'Khodr Tello, MD', 'role': 'CONTACT', 'email': 'khodr.tello@innere.med.uni-giessen.de', 'phone': '+49 641 985', 'phoneExt': '56087'}], 'facility': 'University Hospital Justus-Liebig University', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'centralContacts': [{'name': 'Birgit Assmus, MD', 'role': 'CONTACT', 'email': 'birgit.assmus@innere.med.uni-giessen.de', 'phone': '+49641985', 'phoneExt': '42637'}, {'name': 'Khodr Tello, MD', 'role': 'CONTACT', 'email': 'khodr.tello@innere.med.uni-giessen.de', 'phone': '+49641985', 'phoneExt': '56087'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Giessen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Heart Failure Department, Cardiology', 'investigatorFullName': 'Birgit Assmus', 'investigatorAffiliation': 'University of Giessen'}}}}