Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction

  • STATUS
    Recruiting
  • End date
    Jun 25, 2022
  • participants needed
    30
  • sponsor
    Johann Wolfgang Goethe University Hospital
Updated on 25 January 2021
medical therapy
ejection fraction
heart failure with preserved ejection fraction

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.

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.

Details
Condition diastolic heart failure
Treatment conductance catheter measurement
Clinical Study IdentifierNCT04154657
SponsorJohann Wolfgang Goethe University Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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