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Diastolic Heart FailureHFpEF-StressNCT03260621

CMR Exercise Stress Testing in HFpEF

A study testing stress CMR in people with Diastolic Heart Failure, run by University of Göttingen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients of the University Hospital Göttingen with echocardiographic signs for diastolic heart failure and indication for right heart catheterisation will undergo additional diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic dysfunction and tissue characterisation correlating… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diastolic Heart Failure
What is being tested?
stress CMR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteGermany
Study dates
16 Aug 2017to 1 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients with dyspnoea under stress, echocardiographic criteria for diastolic dysfunction (E/E'>8) and clinical indication for right heart catheterisation

Who cannot join

  • arrhythmia (brady- or tachycardic)
  • bronchial asthma (allergic)
  • incompliant patient
  • pacemaker, ICD, non MRI-capable devices
  • inability to use the ergometer in the MRI
  • haemodynamic relevant valvular heart disease
Show all 16Show fewer
  • pulmonary disease (vital capacity or forced expiratory flow <80% of healthy control)
  • angina pectoris
  • post cardiac infarction
  • anaemia (Hb <12 g/dl)
  • uncontrollable hypertension (>150 mmHg systolic or >100 mmHg diastolic)
  • age <18 years
  • pregnancy
  • claustrophobia
  • renal insufficiency
  • allergic to gadolinium based contrast agents

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Goettingen

    Göttingen, 37073

Other trials in Germany

About this study

Official title: Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction

Patients of the University Hospital Göttingen with echocardiographic signs for diastolic heart failure and indication for right heart catheterisation will undergo additional diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic dysfunction and tissue characterisation correlating the results with well-established clinical standards.

Being tested
stress CMR
Medical subject headings
Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stress CMRDiagnostic test

    additional stress CMR to the established clinical diagnostics

Study groups in NCT03260621
Study groupRoleWhat they receive
echocardiographic increase in left atrial pressureOtherNot described
Receives: Diagnostic Test: stress CMR
echocardiographic no increase in left atrial pressureOtherNot described
Receives: Diagnostic Test: stress CMR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular magnetic resonance imaging

    ventricular and atrial volumes

    Measured: approx. 1 years

  2. Cardiovascular magnetic resonance imaging

    ventricular and atrial mechanics: strain

    Measured: approx. 1 years

  3. Cardiovascular magnetic resonance imaging

    quantification of extracellular volume (ECV)/interstitial fibrosis

    Measured: approx. 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start16 Aug 2017
  3. Primary completion1 Sep 2019
  4. Study completion1 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03260621
Sponsor's protocol ID
35/8/15
Acronym
HFpEF-Stress
Status last verified
Nov 2020
First submitted
10 Aug 2017
Last updated
16 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data acquired within the current study will be available via the german centre for cardiovascular research (DZHK) to researchers who successfully applied to undertake additional scientific studies based on DZHK data.

Publications

  • Backhaus SJ, Schulz A, Lange T, Rosel SF, Schmidt-Schweda LS, Kutty S, Kowallick JT, Treiber J, Rolf A, Sossalla S, Hasenfuss G, Schuster A. Insights from serial cardiovascular magnetic resonance imaging show early progress in diastolic dysfunction relates to impaired right ventricular deformation. Sci Rep. 2025 Feb 3;15(1):4090. doi: 10.1038/s41598-025-87032-5.

    PubMed 39900615

  • Schulz A, Schellinger IN, Backhaus SJ, Adler AS, Lange T, Evertz R, Kowallick JT, Hoffmann A, Matek C, Tsao PS, Hasenfuss G, Raaz U, Schuster A. Association of Cardiac MRI-derived Aortic Stiffness with Early Stages and Progression of Heart Failure with Preserved Ejection Fraction. Radiol Cardiothorac Imaging. 2024 Aug;6(4):e230344. doi: 10.1148/ryct.230344.

    PubMed 39145733

  • Backhaus SJ, Nasopoulou A, Lange T, Schulz A, Evertz R, Kowallick JT, Hasenfuss G, Lamata P, Schuster A. Left Atrial Roof Enlargement Is a Distinct Feature of Heart Failure With Preserved Ejection Fraction. Circ Cardiovasc Imaging. 2024 Jul;17(7):e016424. doi: 10.1161/CIRCIMAGING.123.016424. Epub 2024 Jul 16.

    PubMed 39012942

  • Backhaus SJ, Schulz A, Lange T, Schmidt-Schweda LS, Hellenkamp K, Evertz R, Kowallick JT, Kutty S, Hasenfuss G, Schuster A. Prognostic and diagnostic implications of impaired rest and exercise-stress left atrial compliance in heart failure with preserved ejection fraction: Insights from the HFpEF stress trial. Int J Cardiol. 2024 Jun 1;404:131949. doi: 10.1016/j.ijcard.2024.131949. Epub 2024 Mar 11.

    PubMed 38471649

  • Backhaus SJ, Schulz A, Lange T, Evertz R, Kowallick JT, Hasenfuss G, Schuster A. Rest and exercise-stress estimated pulmonary capillary wedge pressure using real-time free-breathing cardiovascular magnetic resonance imaging. J Cardiovasc Magn Reson. 2024 Summer;26(1):101032. doi: 10.1016/j.jocmr.2024.101032. Epub 2024 Feb 29.

    PubMed 38431079

  • Backhaus SJ, Schulz A, Lange T, Schmidt-Schweda LS, Evertz R, Kowallick J, Hasenfuss G, Schuster A. Real-time cardiovascular magnetic resonance imaging for non-invasive characterisation of heart failure with preserved ejection fraction: final outcomes of the HFpEF stress trial. Clin Res Cardiol. 2024 Mar;113(3):496-508. doi: 10.1007/s00392-023-02363-5. Epub 2024 Jan 3.

    PubMed 38170248

  • Backhaus SJ, Lange T, Schulz A, Evertz R, Frey SM, Hasenfuss G, Schuster A. Cardiovascular magnetic resonance rest and exercise-stress left atrioventricular coupling index to detect diastolic dysfunction. Am J Physiol Heart Circ Physiol. 2023 May 1;324(5):H686-H695. doi: 10.1152/ajpheart.00081.2023. Epub 2023 Mar 10.

    PubMed 36897745

  • Schuster A, Schulz A, Lange T, Evertz R, Hartmann F, Kowallick JT, Hellenkamp K, Uecker M, Seidler T, Hasenfuss G, Backhaus SJ. Concomitant latent pulmonary vascular disease leads to impaired global cardiac performance in heart failure with preserved ejection fraction. Eur J Heart Fail. 2023 Mar;25(3):322-331. doi: 10.1002/ejhf.2781. Epub 2023 Mar 2.

    PubMed 36691723

  • Backhaus SJ, Uzun H, Rosel SF, Schulz A, Lange T, Crawley RJ, Evertz R, Hasenfuss G, Schuster A. Hemodynamic force assessment by cardiovascular magnetic resonance in HFpEF: A case-control substudy from the HFpEF stress trial. EBioMedicine. 2022 Dec;86:104334. doi: 10.1016/j.ebiom.2022.104334. Epub 2022 Nov 21.

    PubMed 36423376

  • Backhaus SJ, Lange T, George EF, Hellenkamp K, Gertz RJ, Billing M, Wachter R, Steinmetz M, Kutty S, Raaz U, Lotz J, Friede T, Uecker M, Hasenfuss G, Seidler T, Schuster A. Exercise Stress Real-Time Cardiac Magnetic Resonance Imaging for Noninvasive Characterization of Heart Failure With Preserved Ejection Fraction: The HFpEF-Stress Trial. Circulation. 2021 Apr 13;143(15):1484-1498. doi: 10.1161/CIRCULATIONAHA.120.051542. Epub 2021 Jan 21.

    PubMed 33472397

Questions about this trial

What is this clinical trial studying?

A study testing stress CMR in people with Diastolic Heart Failure, run by University of Göttingen 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 1 inclusion and 16 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: finished, as of the sponsor's last update on 16 Nov 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cardiovascular magnetic resonance imaging (time frame: approx. 1 years). The study lists 3 primary outcomes in all. 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 NCT03260621, which also lists 10 linked publications.

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 16 Nov 2020.

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