Clinical trial NCT04688905: Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
Official title: Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dyspnea
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unexplained dyspnea NYHA II-III

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: HFpEF-positive patients
timeFrame: Within one day
Secondary outcomes:
measure: H2FPEF score
timeFrame: Within two days
measure: HFA-PEFF score
timeFrame: Within two days
measure: Difference in DPVQ (echocardiographic)
timeFrame: Within two days
measure: Difference in E/E' (echocardiographic)
timeFrame: Within two days
measure: Difference in GLS (echocardiographic)
timeFrame: Within two days
measure: Difference in MRI parameters
timeFrame: Within two days
measure: Difference in pulmonary artery pressure (right heart catheter)
timeFrame: Within two days
measure: Difference in wedge pressure (right heart catheter)
timeFrame: Within two days
measure: Difference in DPVQ (echocardiographic) after one year
timeFrame: 1 year
measure: Difference in E/E' (echocardiographic) after one year
timeFrame: 1 year
measure: Difference in GLS (echocardiographic) after one year
timeFrame: 1 year
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Saxony
Study officials:
References: