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Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction (INTERACT-HFpEF)

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ClinicalTrials.gov Identifier: NCT04154657
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
University of Giessen
Information provided by (Responsible Party):
Birgit Assmus, University of Giessen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Procedure: conductance catheter measurement Not Applicable

Detailed Description:

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.

Thus, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single cohort observational pathophysiologic study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: biventricular conductance catheter
patients with indication for invasive assessment receive right and left heart catheter and parallel biventricular conductance catheter at rest and stress
Procedure: conductance catheter measurement
biventricular parallel conductance catheter measurement at rest and stress conditions, + CMR at rest and stress
Other Name: pressure volume loop catheter measurement




Primary Outcome Measures :
  1. delta Eed [ Time Frame: immediate after procedure ]
    RV stiffness measured by conductance catheter is reduced alreday in early HFpEF stages

  2. delta RV volume [ Time Frame: immediate after procedure ]
    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


Secondary Outcome Measures :
  1. correlation of delta RV longitudinal strain with Eed [ Time Frame: immediate after procedure ]
    RV longitudinal strain (related to RV EDV) is the best predictor of RV diastolic stiffness (Eed) in HFpEF-PH (correlation analysis)

  2. delta transmural septal pressure [ Time Frame: immediate after procedure ]
    acute change of the transmural pressure gradients from rest to stress conditions, adversly impacts LV filling



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Diagnosis of HFpEF as follows

  • Heart failure NYHA II or NYHA III
  • LVEF ≥ 50%
  • HFA-PEFF score ≥ 5 OR HFA-PEFF score 2-4 with one of the following criteria:
  • baseline PCWP ≥ 15 mm Hg OR PCWP increase ≥ 10 mm Hg with exercise (~20 Watt)
  • stable medical therapy for last 4 weeks

Exclusion criteria:

  • Significant coronary stenosis > 50% or valvular heart disease requiring intervention
  • coronary or cardiac valvular intervention < 3 months
  • uncontrolled rate of atrial fibrillation
  • Severe chronic kidney disease (MDRD eGFR < 30 ml/min)
  • Life expectancy < 12 months
  • Contraindication to MRI or other planned investigations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154657


Contacts
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Contact: Birgit Assmus, MD +49641985 ext 42637 birgit.assmus@innere.med.uni-giessen.de
Contact: Khodr Tello, MD +49641985 ext 56087 khodr.tello@innere.med.uni-giessen.de

Locations
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Germany
Goethe University Hospital Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Eike Nagel, MD    +49696301 ext 84491    eike.nagel@kgu.de   
Contact: Valentina M Puntmann, MD    +49696301 ext 84491    valentina.puntmann@kgu.de   
University Hospital Justus-Liebig University Recruiting
Gießen, Germany, 35392
Contact: Birgit Assmus, MD    +49 641 985 ext 42637    birgit.assmus@innere.med.uni-giessen.de   
Contact: Khodr Tello, MD    +49 641 985 ext 56087    khodr.tello@innere.med.uni-giessen.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
University of Giessen
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Responsible Party: Birgit Assmus, Director Heart Failure Department, Cardiology, University of Giessen
ClinicalTrials.gov Identifier: NCT04154657    
Other Study ID Numbers: Interact_HFpEF
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Birgit Assmus, University of Giessen:
HFpEF
pulmonary hypertension
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases