Diastolic Exercise Stress Testing in Heart Failure

Terminated

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Procedure: Right heart catheterization

• Registration Number: NCT04970953
• Lead Sponsor: University Hospital, Essen

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.

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Study Start: 2021-08-09
• Primary Completion: 2023-01-13
• Study Completion: 2023-02-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with intermediate risk for HFpEF at rest	Right heart catheterization	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.

Primary Outcome Measures

Name	Time	Method
PAWP increase across the four stress tests	1 year	Number of patients with an increase of PAWP\<15mmHg at rest to \>25mmHg during stress testing.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinik für Kardiologie und Angiologie-Westdeutsches Herz- und Gefäßzentrum Essen; 🇩🇪 Essen, Nordrhein, Germany