CClinicalTrials.gg
CompletedNCT05322109Updated Apr 11, 2022

Cardiac Magnetic Resonance Tomography for Heart Failure With Preserved Ejection Fraction

An observational study in Heart Failure, Diastolic, sponsored by German Heart Institute. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.

Sponsored by German Heart Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
190
Ages
18 Years and older
Sex
All
01

Study summary

The diagnosis of heart failure with preserved ejection fraction has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function.However, it is still unclear which parameters can be used meaningfully for diagnostics.To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication for CMR and coronary angiography.

Read the detailed description

Heart failure with preserved pump function is a common disease that is associated with a high level of suffering for the patient. The diagnosis has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures.

With its high spatial resolution and the possibility of tissue-specific diagnostics, cardiac MRI (CMR) offers outstanding possibilities in cardiac imaging without exposing the patient to ionizing radiation. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function. However, it is still unclear which parameters can be used meaningfully for diagnostics. There is evidence for a correlation with invasively increased LVEDP, although the number of patients examined in the previous studies was still small. In addition, possible influences from medication and clinical parameters were not examined.

To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication. The significance of the study is that in the future CMR could supplement echocardiography in the diagnosis of HFpEF and further reduce the need for invasive diagnostics.

02

Conditions studied

  • Heart Failure, Diastolic

Keywords

  • cardiac magnetic resonance
  • magnetic resonance imaging
  • lvedp
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 190 is close to the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

German Heart Institute is the lead sponsor of 25 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

atients with CMR and left heart catheterization including LVEDP measurement within the same month

Inclusion criteria

  • Patients with CMR and left heart catheterization including LVEDP measurement within the same month

Exclusion criteria

Exclusion Criteria:

  • Severe Valve Dysfunction or Pericardial/Pleural Disease
  • Contraindictaion for CR or Cath
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
190 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testCMR

    Clinically indicated cardiac magnetic resonance tomography executed according to international guideline recommendations.

    Also known as: Cardiac magnetic resonance tomography

06

What researchers measure

Primary outcomes

  1. Extracellular myocardial volume (%)

    Estimated percentage of extracellular volume of the myocardium

    Time frame: One montth

  2. Left atrial volume (ml)

    Volume of the left atrium in mililiters

    Time frame: One month

07

Study locations

1 site
  • Deutsches Herzzentrum Berlin
    Berlin, 13353, Germany
08

References and documents

Individual participant data

Plan to share: Undecided — Upon reasonable request anonymized IPD may be sharedn at the discretion of the PI.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05322109
Lead sponsor
German Heart Institute
Responsible party
Sebastian Kelle (Principal Investigator, German Heart Institute) — Principal investigator
First posted
Apr 11, 2022
Start date
Apr 23, 2021
Primary completion
Dec 12, 2021
Completion
Dec 12, 2021
Last update
Apr 11, 2022

Oversight

Data monitoring committee
No
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 Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion