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Diastolic Exercise Stress Testing in Heart Failure

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)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04970953
Acronym
DEST-HF
Enrollment
19
Registered
2021-07-21
Start date
2021-08-09
Completion date
2023-02-20
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

diastolic stress testing, HFpEF

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.

Interventions

Right heart catheterization will be performed via a brachial access under sonographic guidance and hemodynamic measurements will be performed in a semi-supine position.

Sponsors

University Hospital, Essen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PAWP increase across the four stress tests1 yearNumber of patients with an increase of PAWP\<15mmHg at rest to \>25mmHg during stress testing.

Secondary

MeasureTime frameDescription
Changes of mean pulmonary artery pressure (mPAP) across the four stress tests1 yearmPAP changes \[mmHg\] during stress testing will be assessed.
Association of PAWP increase and changes of VO2peak during bicycle ergometry1 yearassociations between PAWP \[mmHg\] and VO2peak \[ml/kg/min\] during bicycle ergometry will be assessed.
Changes of pulmonary vascular resistance (PVR) across the four stress tests1 yearPVR changes \[WU, Wood Units\] during stress testing will be assessed.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026