NCT05322109

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

March 3, 2022

Last Update Submit

April 4, 2022

Conditions

Heart Failure, Diastolic

Keywords

cardiac magnetic resonancemagnetic resonance imaginglvedp

Outcome Measures

Primary Outcomes (2)

  • Extracellular myocardial volume (%)

    Estimated percentage of extracellular volume of the myocardium

    One montth

  • Left atrial volume (ml)

    Volume of the left atrium in mililiters

    One month

Interventions

CMRDIAGNOSTIC_TEST

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

Also known as: Cardiac magnetic resonance tomography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2022

First Posted

April 11, 2022

Study Start

April 23, 2021

Primary Completion

December 12, 2021

Study Completion

December 12, 2021

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations

DE(1)