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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Procedure: Right heart catheterization

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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Germany
  • Nordrhein
    • Essen, Nordrhein, Germany, 45122
      • Klinik für Kardiologie und Angiologie-Westdeutsches Herz- und Gefäßzentrum Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Right heart catheterization will be performed via a brachial access under sonographic guidance and hemodynamic measurements will be performed in a semi-supine position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of mean pulmonary artery pressure (mPAP) across the four stress tests	mPAP changes [mmHg] during stress testing will be assessed.	1 year
Association of PAWP increase and changes of VO2peak during bicycle ergometry	associations between PAWP [mmHg] and VO2peak [ml/kg/min] during bicycle ergometry will be assessed.	1 year
Changes of pulmonary vascular resistance (PVR) across the four stress tests	PVR changes [WU, Wood Units] during stress testing will be assessed.	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Investigators: Principal Investigator: Peter Lüdike, Professor, University Hopsital Duisburg-Essen

Publications and helpful links

General Publications

• 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. Erratum In: Eur Heart J. 2021 Mar 31;42(13):1274.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HFpEF; diastolic stress testing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 21-9993-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No