Clinical trial NCT04970953: Diastolic Exercise Stress Testing in Heart Failure
Official title: 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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: diastolic stress testing
HFpEF
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: PAWP increase across the four stress tests
timeFrame: 1 year
Secondary outcomes:
measure: Changes of mean pulmonary artery pressure (mPAP) across the four stress tests
timeFrame: 1 year
measure: Association of PAWP increase and changes of VO2peak during bicycle ergometry
timeFrame: 1 year
measure: Changes of pulmonary vascular resistance (PVR) across the four stress tests
timeFrame: 1 year
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinik für Kardiologie und Angiologie-Westdeutsches Herz- und Gefäßzentrum Essen
state: Nordrhein
Study officials:
affiliation: University Hopsital Duisburg-Essen
name: Peter Lüdike, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pieske B, Tschope C, de Boer RA, Fraser AG, Anker SD, Donal E, Edelmann F, Fu M, Guazzi M, Lam CSP, Lancellotti P, Melenovsky V, Morris DA, Nagel E, Pieske-Kraigher E, Ponikowski P, Solomon SD, Vasan RS, Rutten FH, Voors AA, Ruschitzka F, Paulus WJ, Seferovic P, Filippatos G. How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur Heart J. 2019 Oct 21;40(40):3297-3317. doi: 10.1093/eurheartj/ehz641.