ClinicalTrials.gg
CompletedNCT03260621HFpEF-StressUpdated Nov 16, 2020

CMR Exercise Stress Testing in HFpEF

An interventional study of stress CMR in Diastolic Heart Failure, sponsored by University of Göttingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-16.

Sponsored by University of Göttingen · Not applicable, Interventional, and Diagnostic

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Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Heart Failure, Diastolic with a site in Germany — 1 open to participants now, 2 under way, none of them phase 3. Heart Failure, Diastolic · Germany.

Enrollment
6th of 12
75 · median 61
Started
2017
the only one that year
No phase
8 of 15
none open now
Registered
7th of 15
by date

Among the 15 studies in Heart Failure, Diastolic with a site in Germany, this one is the 6th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2017, is one of 8 with no phase, and was the 7th registered.

Heart Failure, Diastolic

199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.

Browse Heart Failure, Diastolic studies →

Open to participants now

1 of the 15 studies in Heart Failure, Diastolic with a site in Germany is open now. Recruiting first, the newest first:

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 29 Heart Failure, Diastolic studies recruiting now, 21 (72%) set no upper age limit and 4 (14%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 the results with well-established clinical standards.

03

Conditions studied

  • Diastolic Heart Failure
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
  • pulmonary disease (vital capacity or forced expiratory flow \<80% of healthy control)
  • angina pectoris
  • post cardiac infarction
  • anaemia ( \<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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Other
    echocardiographic increase in left atrial pressure

    Diagnostic Test: stress CMR

  • Other
    echocardiographic no increase in left atrial pressure

    Diagnostic Test: stress CMR

Interventions

  • Diagnostic teststress CMR

    additional stress CMR to the established clinical diagnostics

06

What researchers measure

Primary outcomes

  1. Cardiovascular magnetic resonance imaging

    ventricular and atrial volumes

    Time frame: approx. 1 years

  2. Cardiovascular magnetic resonance imaging

    ventricular and atrial mechanics: strain

    Time frame: approx. 1 years

  3. Cardiovascular magnetic resonance imaging

    quantification of extracellular volume (ECV)/interstitial fibrosis

    Time frame: approx. 1 years

Other outcomes

  1. Exercise spirometry

    maximal oxygen uptake

    Time frame: approx. 1 years

  2. Exercise spirometry

    respiratory quotient

    Time frame: approx. 1 years

  3. Exercise spirometry

    power (watt/kg)

    Time frame: approx. 1 years

  4. Right heart catheterization

    reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure

    Time frame: approx. 1 years

07

Study locations

1 site
  • University Hospital Goettingen
    Göttingen, 37073, Germany
08

References and documents

Publications

  • 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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Sep 2019, 24 months.

Of 39 non-industry interventional studies with no phase under Heart Failure, Diastolic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 57. This study's 24 months is below that.

Counting every sponsor, half of 45 studies reached it within 48 months; a quarter within 26 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2017
First posted
Aug 24, 2017
StartActual
Aug 16, 2017
Primary completionActual
Sep 1, 2019
CompletionActual
Sep 1, 2020
Last update
Nov 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03260621
Lead sponsor
University of Göttingen
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Responsible party
Andreas Schuster (PD Dr. med, University of Göttingen) — Principal investigator
First posted
Aug 24, 2017
Start date
Aug 16, 2017
Primary completion
Sep 1, 2019
Completion
Sep 1, 2020
Last update
Nov 16, 2020

Study contacts

Andreas Schuster, MD, PhD
principal investigator · University of Göttingen

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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