DyspneaNCT04688905
Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
An observational study of Dyspnea, run by University of Leipzig at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2020to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unexplained dyspnea NYHA II-III
Who may be able to join
- dyspnea NYHA II-III
- age 18-90 years
- left ventricular ejection fraction ≥ 50%
- ability to give informed consent
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Dyspnea
- Being tested
- Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusionDiagnostic test
Also called Cardiac MRI at rest, Echocardiography at rest and with exercise, Spiroergometry, 6 minute walking distance
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyspnea explained by heart failure with preserved ejection fraction | All patients fulfilling invasive criteria for heart failure with preserved ejection fraction Receives: Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion | |
| Dyspnea not explained by heart failure with preserved ejection fraction | All patients not fulfilling invasive criteria for heart failure with preserved ejection fraction Receives: Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFpEF-positive patients
Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction
Measured: Within one day
Secondary outcomes (11)
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)
Measured: 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.
Measured: Within two days
Difference in DPVQ (echocardiographic)
Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF
Measured: Within two days
Difference in E/E' (echocardiographic)
E/E' (at rest and under exertion) in patients with approved and excluded HFpEF
Measured: Within two days
Difference in GLS (echocardiographic)
Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF
Measured: Within two days
Difference in MRI parameters
Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF
Measured: 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
Measured: Within two days
Difference in wedge pressure (right heart catheter)
Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF
Measured: 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
Measured: 1 year
Difference in E/E' (echocardiographic) after one year
E/E' at rest in patients with approved and excluded HFpEF after one year
Measured: 1 year
Difference in GLS (echocardiographic) after one year
Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start9 Sep 2020
- Primary completion4 Aug 2023
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Wachter, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688905
- Sponsor's protocol ID
- 283/20
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2020
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable scientific request.
Publications
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.
PubMed 41233022
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)
- ClinicalTrials.gov ID
- NCT04688905
- Acronym / sponsor ID
- 283/20
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyspnea explained by 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 occlusionAll patients fulfilling invasive criteria for heart failure with preserved ejection fraction |
| Dyspnea not explained by 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 occlusionAll patients not fulfilling invasive criteria for heart failure with preserved ejection fraction |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unexplained dyspnea NYHA II-III
Key inclusion criteria (4 listed)
- dyspnea NYHA II-III
- age 18-90 years
- left ventricular ejection fraction ≥ 50%
- ability to give informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusionAlso: Cardiac MRI at rest, Echocardiography at rest and with exercise, Spiroergometry, 6 minute walking distanceInvasive 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. | Diagnostic test | Dyspnea explained by heart failure with preserved ejection fraction, Dyspnea not explained by heart failure with preserved ejection fraction |
Primary outcome
HFpEF-positive patients
Time frame: Within one day
Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction
11 secondary outcomes
H2FPEF score
Time frame: Within two days
HFA-PEFF score
Time frame: Within two days
Difference in DPVQ (echocardiographic)
Time frame: Within two days
Difference in E/E' (echocardiographic)
Time frame: Within two days
Difference in GLS (echocardiographic)
Time frame: Within two days
Difference in MRI parameters
Time frame: Within two days
Difference in pulmonary artery pressure (right heart catheter)
Time frame: Within two days
Difference in wedge pressure (right heart catheter)
Time frame: Within two days
Difference in DPVQ (echocardiographic) after one year
Time frame: 1 year
Difference in E/E' (echocardiographic) after one year
Time frame: 1 year
Difference in GLS (echocardiographic) after one year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 41233022Gessner 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.
- Individual participant dataSharing planned: Undecided. Available upon reasonable scientific request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFpEF-positive patients (time frame: Within one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.