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

N/AActive Not RecruitingNCT04688905

University of Leipzig30 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dyspnea

Interventions

Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusionDIAGNOSTIC_TEST

Invasive 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Outcomes

Primary Outcomes

HFpEF-positive patients

Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction

Time frame: Within one day

Secondary Outcomes

H2FPEF score

Difference in H2FPEF score in patients with approved and excluded HFpEF (BMI \> 30 kg/m²: 2 points, 2 or more antihypertensive medicines: 1 point, atrial fibrillation: 3 points, pulmonary hypertension: 1 point, age \> 60 years: 1 point, E/E' \> 9: 1 point. Sum: 0-9 points with rising probability of HFpEF with increasing score)

Time frame: Within two days

HFA-PEFF score

Difference in HFA-PEFF score in patients with approved and excluded HFpEF (0-2 points regarding functional, morpholigical and biomarker parameters. Sum: 0-6 points; 0-1 points:exclusion of HFpEF, 2-5 points: further diagnostic (stress test or invasive) required, 5-6 points: HFpEF diagnosed.

Time frame: Within two days

Difference in DPVQ (echocardiographic)

Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF

Time frame: Within two days

Difference in E/E' (echocardiographic)

E/E' (at rest and under exertion) in patients with approved and excluded HFpEF

Time frame: Within two days

Difference in GLS (echocardiographic)

Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF

Time frame: Within two days

Difference in MRI parameters

Data from ClinicalTrials.gov

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