Cardiac Magnetic Resonance Tomography for Heart Failure With Preserved Ejection Fraction

Heart Failure, Diastolic Clinical Trial

Official title:

Diagnostic Accuracy of Cardiac Magnetic Resonance Tomography (CMR) for Heart Failure With Preserved Ejection Fraction (HFpEF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322109
• Other study ID #: EA2/017/22
• Status: Completed
• Start date: April 23, 2021
• Est. completion date: December 12, 2021

Study information

• Verified date: April 2022
• Source: German Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 12, 2021
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

Diagnostic Test:
• CMR
Clinically indicated cardiac magnetic resonance tomography executed according to international guideline recommendations.

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
German Heart Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extracellular myocardial volume (%)	Estimated percentage of extracellular volume of the myocardium	One montth
Primary	Left atrial volume (ml)	Volume of the left atrium in mililiters	One month