Dyspnea
Conditions
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.
Interventions
DIAGNOSTIC_TESTInvasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion
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.
Sponsors
University of Leipzig
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HFpEF-positive patients | Within one day | Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| H2FPEF score | Within two days | 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) |
| HFA-PEFF score | Within two days | 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. |
| Difference in DPVQ (echocardiographic) | Within two days | Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF |
| Difference in E/E' (echocardiographic) | Within two days | E/E' (at rest and under exertion) in patients with approved and excluded HFpEF |
| Difference in GLS (echocardiographic) | Within two days | Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF |
| Difference in DPVQ (echocardiographic) after one year | 1 year | Diastolic pressure-volume quotient (DPVQ) at rest in patients with approved and excluded HFpEF after one year |
| Difference in pulmonary artery pressure (right heart catheter) | Within two days | Pulmonary artery pressure at rest and under exertion in patients with approved and excluded HFpEF |
| Difference in wedge pressure (right heart catheter) | Within two days | Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF |
| Difference in E/E' (echocardiographic) after one year | 1 year | E/E' at rest in patients with approved and excluded HFpEF after one year |
| Difference in GLS (echocardiographic) after one year | 1 year | Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year |
| Difference in MRI parameters | Within two days | Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF |
Countries
Germany
Outcome results
None listed