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SPIRIT-HF-DZHK8

SPIRonolactone In the Treatment for Heart Failure (SPIRIT-HF-DZHK8)

The SPIRIT-HF-DZHK8 study investigates whether the drug spironolactone can reduce the number of people with preserved ejection fraction who end up in hospital and the number of people who die from heart failure. Currently, there is no cure for this type of heart failure.

Previous studies with spironolactone have not yet given any clear results for people affected by preserved ejection fraction. The SPIRIT-HF study will differ to previous research because there will be only patients included conclusively diagnosed with poor dilation of the heart chambers.

When someone has heart failure, they overproduce the hormone aldosterone. Excess aldosterone causes heart remodelling. Vital, flexible heart muscle cells are replaced with more rigid connective tissue cells, with no useful function. As a result, the heart’s performance is greatly reduced. Spironolactone blocks the effect of aldosterone and could slow down or stop the remodelling processes that weaken the heart in heart failure.

SPIRIT-HF-DZHK8 is a double-blind phase III study. 35 study sites in Germany, as well as participants and hospitals in Austria, France, the Netherlands and Serbia are involved in the study.

More information: https://spirit-hf.dzhk.de/

Principal Investigators

Principal investigator: Frank Edelmann (Berlin) (vormals Burkert Pieske)

Medical institution

Charité – Universitätsmedizin Berlin (CVK)

Keywords

heart failure

Recruitment start

11/2018

Patients (planned)

1300

Patients (recruited)

733 (completed)

ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT04727073

EudraCT Nr.: 2017-000697-11