Diastolic Exercise Stress Testing in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-09

Study Completion Date

2023-02-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Right Ventricular Function and Pulmonary Hypertension in HFpEF

NCT05055180

Heart Failure With Preserved Ejection Fraction

UNKNOWN

Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot

NCT00564993

Tetralogy of Fallot

TERMINATED PHASE3

Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)

NCT04688905

Dyspnea

ACTIVE_NOT_RECRUITING

Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

NCT02751853

Heart Failure

TERMINATED NA

The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion

NCT05490901

Heart Failure With Preserved Ejection Fraction Chronic Pulmonary Thromboembolism (Disorder)

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure With Preserved Ejection Fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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