Diastolic Exercise Stress Testing in Heart Failure

NCT04970953 | Terminated

• 1 other identifier: 21-9993-BO
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

diastolic stress testing; HFpEF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes of mean pulmonary artery pressure (mPAP) across the four stress tests

  1 year

• 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

Study Arms (1)

Patients with intermediate risk for HFpEF at rest

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

Interventions

Right heart catheterization PROCEDURE

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

Patients with intermediate risk for HFpEF at rest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Consent for study participation not obtained
• Age \< 18 years
• Medical contraindications to perform right heart catheterization

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

Klinik für Kardiologie und Angiologie-Westdeutsches Herz- und Gefäßzentrum Essen

Essen, Nordrhein, 45122, Germany

Location

Related Publications (1)

• 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.

  PMID: 31504452 RESULT

Study Officials

• Peter Lüdike, Professor

  University Hopsital Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 21, 2021
• Study Start: August 9, 2021
• Primary Completion: January 13, 2023
• Study Completion: February 20, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)