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Active Not RecruitingNCT04688905

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

Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
University of Leipzig · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools

Detailed description

Multiple diagnostic tests, including stress tests and the invasive conduction of left ventricular pressure-volume loops via conductance catheter (as gold standard) will be performed in patients with unexplained dyspnea NYHA II-III in order to identify patients with a heart failure with preserved ejection fraction (HFpEF). The results will be compared to previously reported diagnostic scores such as the H2FPEF and the HFA-PEFF score.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTInvasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusionInvasive hemodynamics of left ventricle will be done by the conductance method. Left ventricular stiffness constant will be obtained by temporary vena cava occlusion. Right heart catherization will be done by pulmonary artery catherization and cardiac output will be estimated by thermodilution and Fick´s method.

Timeline

Start date
2020-09-09
Primary completion
2023-08-04
Completion
2026-08-30
First posted
2020-12-30
Last updated
2025-11-19

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04688905. Inclusion in this directory is not an endorsement.