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

Dyspnea Clinical Trial

Official title:

Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04688905
• Other study ID #: 283/20
• Status: Active, not recruiting
• Start date: September 9, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Dyspnea

Intervention

Diagnostic Test:
• Invasive 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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

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