Clinical trial NCT05322109: Cardiac Magnetic Resonance Tomography for Heart Failure With Preserved Ejection Fraction
Official title: Diagnostic Accuracy of Cardiac Magnetic Resonance Tomography (CMR) for Heart Failure With Preserved Ejection Fraction (HFpEF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Diastolic
Keywords: cardiac magnetic resonance
magnetic resonance imaging
lvedp
Lead sponsor: German Heart Institute
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: atients with CMR and left heart catheterization including LVEDP measurement within the same month

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Extracellular myocardial volume (%)
timeFrame: One montth
measure: Left atrial volume (ml)
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
Study officials:
References: