Diastolic Exercise Stress Testing in Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Analysis of Diastolic Stress Tests to Detect Exercise Induced Heart Failure With Preserved Ejection Fraction (HFpEF) in Patients With Intermediate Risk (DEST-HF Study, Diastolic Exercise Stress Testing in Heart Failure)

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Procedure: Right heart catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Unclear etiology of dyspnea with non-invasive testing HFA-PEFF score 2-4 points and thus an intermediate risk for HFpEF Willingness to participate and obtained written consent Exclusion Criteria: Consent for study participation not obtained Age < 18 years Medical contraindications to perform right heart catheterization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with intermediate risk for HFpEF at rest<br>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<br>* Right heart catheterization will be performed via a brachial access under sonographic guidance and hemodynamic measurements will be performed in a semi-supine position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAWP increase across the four stress tests | Number of patients with an increase of PAWP<15mmHg at rest to >25mmHg during stress testing. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of mean pulmonary artery pressure (mPAP) across the four stress tests | mPAP changes [mmHg] during stress testing will be assessed. | 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. | 1 year | 
| Changes of pulmonary vascular resistance (PVR) across the four stress tests | PVR changes [WU, Wood Units] during stress testing will be assessed. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diastolic stress testing, HFpEF