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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dyspnea
• Intervention / Treatment: Diagnostic test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

• Study Contact: Name: Rolf Wachter, MD; Phone Number: +49-341-97-12825; Email: rolf.wachter@medizin.uni-leipzig.de
• Study Contact Backup: Name: Romy Langhammer, MD; Phone Number: +49-341-97-20523; Email: romy.langhammer@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Universitatsklinikum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with unexplained dyspnea NYHA II-III

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dyspnea explained by heart failure with preserved ejection fraction; All patients fulfilling invasive criteria for heart failure with preserved ejection fraction	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.; Other Names: Cardiac MRI at rest; Echocardiography at rest and with exercise; Spiroergometry; 6 minute walking distance; Right heart catherization at rest and with exercise; Coronary angiography (if not performed within the last year)
Dyspnea not explained by heart failure with preserved ejection fraction; All patients not fulfilling invasive criteria for heart failure with preserved ejection fraction	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.; Other Names: Cardiac MRI at rest; Echocardiography at rest and with exercise; Spiroergometry; 6 minute walking distance; Right heart catherization at rest and with exercise; Coronary angiography (if not performed within the last year)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HFpEF-positive patients	Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction	Within one day

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): August 4, 2023
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: 283/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available upon reasonable scientific request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No