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Decipher HFpEF-DZHK12

Validation of Cardiovascular Magnetic Resonance against Invasive Haemodynamics in Patients with Heart Failure with Preserved Ejection Fraction (Decipher HFpEF-DZHK12)

The DECIPHER HFpEF-DZHK12 study investigates whether diastolic heart failure can be better diagnosed and its causes clarified with the help of cardiovascular magnetic resonance imaging (CMR). In the case of a positive outcome, the study would lead to a modification of the guidelines for diagnosing heart failure with preserved ejection fraction (HFpEF).

The problem with HFpEF is that the left ventricle is stiff and does not sufficiently fill with blood. With the non-invasive methods currently used, such as an ultrasound examination, this is hard to measure and is often only identified late. The study compares the CMR data with the results of the present gold standard in the diagnosis of HFpEF, invasive hemodynamics, where patients are examined using a cardiac catheter. In order to obtain a comprehensive picture of the validity of CMR, the study compares the CMR measurements with the results of ultrasound examinations and analyses of myocardial tissue samples.

Using these data, the researchers aim to investigate whether CMR can help clarify why the disease arises, especially since the underlying cause of diastolic heart failure can vary greatly. For example, it can be caused by an inflammation of the heart muscle (myocardium), thickening of the myocardium, or decreased blood flow to the myocardium due to changes to the smallest blood vessels.

CMR procedures developed in recent years enable these parameters to be assessed and are for the first time merged in a combined examination in the study. This is because, unlike an ultrasound examination, these new procedures can not only measure the flow and filling of the ventricle, but also see, whether the heart muscle is inflamed, whether there is a pathological proliferation of the connective tissue, or whether there is a change to the small vessels.

Significant therapeutic studies are only possible once we can distinguish between the various patient subgroups. DECIPHER HFpEF-DZHK12 aims to lay the foundation for this. It is the first multicentre study on the diagnosis of HFpEF worldwide. Beside Frankfurt am Main, the DZHK sites in Berlin, Heidelberg, Göttingen, and Bad Nauheim are also participating.

More information: http://www.cardiac-imaging.org/decipher--hfpef.html

Principal Investigators

Principal investigator: Eike Nagel (Frankfurt)

Medical institution

Universitätsklinikum Frankfurt

Keywords

Recruitment start

01/2018

Patients (planned)

185

Patients (recruited)

170 (completed)

ClinicalTrials.gov

NCT03251183