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Diastolic Exercise Stress Testing in Heart Failure (DEST-HF)

U

University Hospital Essen

Status

Terminated

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Procedure: Right heart catheterization

Study type

Observational

Funder types

Other

Identifiers

NCT04970953
21-9993-BO

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

19 participants in 1 patient group

Patients with intermediate risk for HFpEF at rest
Description:
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.
Treatment:
Procedure: Right heart catheterization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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