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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyspnea explained by heart failure with preserved ejection fraction | All patients fulfilling invasive criteria for heart failure with preserved ejection fraction |
| |
| Dyspnea not explained by heart failure with preserved ejection fraction | All patients not fulfilling invasive criteria for heart failure with preserved ejection fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HFpEF-positive patients | Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction | Within one day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unexplained dyspnea NYHA II-III
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41233022 | Result | Gessner R, Hubner AC, Stobe S, Rudolph UM, Unger L, Schmeisser A, Steendijk P, Uhe T, Stegmann T, Lavall D, Hagendorff A, Laufs U, Wachter R. Diagnosing HFpEF in Patients With Unexplained Dyspnea by Using Invasive Left Ventricular Pressure-Volume Loops. J Card Fail. 2025 Nov;31(11):1661-1671. doi: 10.1016/j.cardfail.2025.09.010. |
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Available upon reasonable scientific request.
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Approximately 40 ml of blood will be drawn for the conduction of hemogram, sodium, potassium, creatine, eGFR, urea, coagulation, TSH, CK, high-sensitivity troponin T, NT-proBNP, HbA1c, lipids, iron status as well as biobanking (at -80°C) for 15 years.
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| 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 |
| Difference in DPVQ (echocardiographic) | Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days |
| Difference in E/E' (echocardiographic) | E/E' (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days |
| Difference in GLS (echocardiographic) | Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF | Within two days |
| Difference in MRI parameters | Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF | Within two days |
| 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 |
| Difference in wedge pressure (right heart catheter) | Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF | Within two days |
| 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 |
| Difference in E/E' (echocardiographic) after one year | E/E' at rest in patients with approved and excluded HFpEF after one year | 1 year |
| Difference in GLS (echocardiographic) after one year | Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year | 1 year |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017023 | Coronary Angiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D006334 | Heart Function Tests |
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