Diastolic Exercise Stress Testing in Heart Failure

Heart Failure With Preserved Ejection Fraction Clinical Trial

— DEST-HF  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04970953
• Other study ID #: 21-9993-BO
• Status: Terminated
• Start date: August 9, 2021
• Est. completion date: February 20, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 20, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinik für Kardiologie und Angiologie-Westdeutsches Herz- und Gefäßzentrum Essen	Essen	Nordrhein

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & 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, Sefer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of mean pulmonary artery pressure (mPAP) across the four stress tests	mPAP changes [mmHg] during stress testing will be assessed.	1 year
Secondary	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
Secondary	Changes of pulmonary vascular resistance (PVR) across the four stress tests	PVR changes [WU, Wood Units] during stress testing will be assessed.	1 year