Diastolic Exercise Stress Testing in Heart Failure (DEST-HF)
May 9, 2023 updated by: Peter Lüdike, University Hospital, Essen
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nordrhein
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Essen, Nordrhein, Germany, 45122
- Klinik für Kardiologie und Angiologie-Westdeutsches Herz- und Gefäßzentrum Essen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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.
|
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
Time Frame: 1 year
|
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
Time Frame: 1 year
|
mPAP changes [mmHg] during stress testing will be assessed.
|
1 year
|
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Association of PAWP increase and changes of VO2peak during bicycle ergometry
Time Frame: 1 year
|
associations between PAWP [mmHg] and VO2peak [ml/kg/min] during bicycle ergometry will be assessed.
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1 year
|
|
Changes of pulmonary vascular resistance (PVR) across the four stress tests
Time Frame: 1 year
|
PVR changes [WU, Wood Units] during stress testing will be assessed.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Lüdike, Professor, University Hopsital Duisburg-Essen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
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