Applicability of past and ongoing steroidal and non-steroidal mineralocorticoid receptor antagonist trials in real-world patients with heart failure with reduced, mildly reduced, and preserved ejection fraction

04/08/2025
04/08/2025
EU PAS number:
EUPAS1000000692
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000692

Study ID

1000000692

Official title and acronym

Applicability of past and ongoing steroidal and non-steroidal mineralocorticoid receptor antagonist trials in real-world patients with heart failure with reduced, mildly reduced, and preserved ejection fraction

DARWIN EU® study

No

Study countries

Sweden

Study description

Steroidal mineralocorticoid receptor antagonists (sMRA) are core pillars in the treatment of patients with heart failure (HF) with reduced ejection fraction (HFrEF), while the evidence for HF with mildly reduced (HFmrEF) and preserved ejection fraction (HFpEF) is more ambiguous.
The novel non-steroidal MRAs (nsMRAs) present a new opportunity to target the MR in HF, with potentially lesser risk of adverse drug reactions such as hyperkalaemia.

We aim to assess the eligibility of a real-world HF population (Swedish Heart Failure Registry) to past and ongoing MRA trials to explore their generalisability, and to identify key inclusion and exclusion criteria to inform future trial design.

Study status

Ongoing
Research institutions and networks

Institutions

Karolinska Institutet
Sweden
First published:
01/02/2024
Institution Educational Institution

Contact details

Benedikt Beer 0000-0003-4315-2533

Primary lead investigator
ORCID number:
0000-0003-4315-2533

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EU institutional research programme
Other public funding (e.g. hospital or university)

More details on funding

This work is supported by the Horizon Europe programme (project number 101095479 - More-EUROPA), and the Swedish Heart and Lung Foundation (project number 20220680) to Dr. Gianluigi Savarese´s institution.
Dr. Benedikt Beer is supported by a grant of the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation; grant number 535014557).
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable