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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- University Hospital, Essen
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- PAWP increase across the four stress tests
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Peter Lüdike
Professor of Cardiology
University Hospital, Essen
Eligibility Criteria
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
Outcomes
Primary Outcomes
PAWP increase across the four stress tests
Time Frame: 1 year
Number of patients with an increase of PAWP\<15mmHg at rest to \>25mmHg during stress testing.
Secondary Outcomes
- Association of PAWP increase and changes of VO2peak during bicycle ergometry(1 year)
- Changes of pulmonary vascular resistance (PVR) across the four stress tests(1 year)
- Changes of mean pulmonary artery pressure (mPAP) across the four stress tests(1 year)