Dyspnea Clinical Trial
Official title:
Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)
Verified date | April 2024 |
Source | University of Leipzig |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Leipzig | Leipzig | Saxony |
Lead Sponsor | Collaborator |
---|---|
University of Leipzig |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HFpEF-positive patients | Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction | Within one day | |
Secondary | 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) | Within two days | |
Secondary | 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. | Within two days | |
Secondary | Difference in DPVQ (echocardiographic) | Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days | |
Secondary | Difference in E/E' (echocardiographic) | E/E' (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days | |
Secondary | Difference in GLS (echocardiographic) | Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days | |
Secondary | Difference in MRI parameters | Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF | Within two days | |
Secondary | Difference in pulmonary artery pressure (right heart catheter) | Pulmonary artery pressure at rest and under exertion in patients with approved and excluded HFpEF | Within two days | |
Secondary | Difference in wedge pressure (right heart catheter) | Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF | Within two days | |
Secondary | Difference in DPVQ (echocardiographic) after one year | Diastolic pressure-volume quotient (DPVQ) at rest in patients with approved and excluded HFpEF after one year | 1 year | |
Secondary | Difference in E/E' (echocardiographic) after one year | E/E' at rest in patients with approved and excluded HFpEF after one year | 1 year | |
Secondary | Difference in GLS (echocardiographic) after one year | Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year | 1 year |
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