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

University of Leipzig

Status: Active, not recruiting

Conditions: Dyspnea

Treatments: Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion

Study type: Observational

Funder types: Other

Identifiers

NCT04688905

283/20

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• dyspnea NYHA II-III
• age 18-90 years
• left ventricular ejection fraction ≥ 50%
• ability to give informed consent

Exclusion criteria

• unstable cardiac disease with acute decompensation
• documented former LVEF ≤ 40%
• heart valve disease with medium or high grade insufficiency or stenosis
• coronary heart disease with hemodynamically relevant coronary stenosis
• specific cardiomyopathia
• acute or chronic cardiac inflammation (myocarditis, pericarditis)
• former heart transplantation
• relevant pulmonary disease (e.g. COPD) assumably causing the dyspnea
• FEV1/VC < 70%
• hemoglobin < 5 mmol/l
• pregnant or nursing women
• contraindication for one of the diagnostic tests

Trial design

30 participants in 2 patient groups

Dyspnea explained by heart failure with preserved ejection fraction

Description:

All patients fulfilling invasive criteria for heart failure with preserved ejection fraction

Treatment:

Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion

Dyspnea not explained by heart failure with preserved ejection fraction

Description:

All patients not fulfilling invasive criteria for heart failure with preserved ejection fraction

Treatment:

Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion