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NCT03251183: DECIPHER-HFpEF

Validation of CMR Against Invasive Haemodynamics in Patients With HFpEF

Completed Last updated 10 March 2023
What this trial tests

trial testing Comprehensive Cardiovascular magnetic resonance (CMR) in Heart Failure With Normal Ejection Fraction in 185 participants. Completed in 31 December 2022.

Timeline
14 January 2018
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorGoethe University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment185
Start date14 January 2018
Primary completion31 December 2022
Estimated completion31 December 2022
Sites7 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Goethe University

Who can join

18 and older, any sex, with Heart Failure With Normal Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people \>75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no non-invasive measure provides a clear diagnosis. Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation of heart structure and function. New CMR parameters offer the possibility to describe the underlying pathological and physiological changes associated with HFpEF. The investigators propose to undertake the first systematic comparison between a CMR protocol and invasive haemodynamics as the best possible gold standard, as well as define the histopathological drivers in myocardial biopsies. The investigators will also examine the relations with tissue and serological biomarkers implicated in HFpEF and the role with standard and novel parameters by echocardiography. If successful, this study will provide tools for a reliable and accurate non-invasive characterization of patients with HFpEF, supporting the diagnosis and grading the severity of disease. This study will provide a reference basis for future diagnostic algorithms in HFpEF, both, for CMR and echocardiography, but also for their relative value in comparison to blood markers or invasive testing. In addition to a new pathway to acess the effects of current and novel therapeutic interventions, the investigators see the greatest potential in identifying a disease stage where the myocardial injury may be reversible.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. STAT3 expression is reduced in cardiac pericytes in HFpEF and its loss reduces cellular adhesion and induces pericyte senescence.
    Vanicek LR, Fischer A, Ruz Jurado M, Tamiato A, et al · · 2025 · PMID 40309782 · DOI 10.1002/1873-3468.70057

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Other recruiting trials for Heart Failure With Normal Ejection Fraction

Currently open trials in the same condition.

Other Goethe University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03251183.

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