An observational study in Heart Failure With Preserved Ejection Fraction, sponsored by University Hospital, Essen. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University Hospital, Essen · Observational
Patients with an intermediate risk (HFA-PEFF score 2-4 points) for heart failure with preserved ejection fraction (HFpEF) will be further investigated with invasive right heart catheterization. All patients with a resting pulmonary artery wedge pressure (PAWP) \<15mmHg will undergo the following stress test modalities in a randomized order: (1) bicycle ergometry, (2) dynamic handgrip exercise, (3) 500ml fluid challenge over 5 minutes, (4) leg raise testing. Exercise induced HFpEF will be diagnosed if PAWP rises to >25mmHg.
Patients reporting to the investigators' clinic for in- and outpatient consultation and a HFA-PEFF score of 2-4 points will be recruited if their dyspnea is not sufficiently explained by other causes than HFpEF. Patients will undergo a baseline clinical exam, transthoracic echocardiography with measurement of diastolic parameters, and ECG. NYHA class will be reported, standard lab works (NTproBNP, GFR, CRP, Hb, PLT, blood gas analysis) will be taken. The number of patients with a PAWP increase in right heart catheterization (brachial access under sonographic guidance) from a resting value of \<15mmHg to >25mmHg during stress testing will be assessed across the four interventions. During bicycle ergometry (semi-supine position) spiroergometric data and gas exchange variables (cardiopulmonary exercise testing) will be co-assessed. Between the testing modalities a 10-minute break will allow hemodynamic variables to normalize.
University Hospital, Essen is the lead sponsor of 116 studies on the registry; 33 are open to participants now.
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Patients reporting to the investigators' in- and outpatient clinic with unsolved dyspnea through non-invasive testing and a HFA-PEFF score 2-4 points and thus an intermediate risk for HFpEF. Following the diagnostic algorithm of HFpEF invasive stress testing is indicated.
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Exclusion Criteria:
Patients with a HFA-PEFF score of 2-4 points and no obvious extracardiac explanation for exercise-induced dyspnea. Right heart catheterization with be performed at rest and during stress testing.
Procedure: Right heart catheterization
Right heart catheterization will be performed via a brachial access under sonographic guidance and hemodynamic measurements will be performed in a semi-supine position.
PAWP increase across the four stress tests
Number of patients with an increase of PAWP\<15mmHg at rest to \>25mmHg during stress testing.
Time frame: 1 year
Changes of mean pulmonary artery pressure (mPAP) across the four stress tests
mPAP changes \[mmHg\] during stress testing will be assessed.
Time frame: 1 year
Association of PAWP increase and changes of VO2peak during bicycle ergometry
associations between PAWP \[mmHg\] and VO2peak \[ml/kg/min\] during bicycle ergometry will be assessed.
Time frame: 1 year
Changes of pulmonary vascular resistance (PVR) across the four stress tests
PVR changes \[WU, Wood Units\] during stress testing will be assessed.
Time frame: 1 year
Plan to share: No
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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