CompletedNot Applicable

Comparative Effects of Methylprednisolone and Prednisolone on the Risk of Acute Decompensated Heart Failure - An Emulated Target Trial

12,000 participantsStarted 2010-01-01

Plain-language summary

The investigators aim to emulate a target trial to compare the risk of acute decompensated heart failure in users of methylprednisolone compared to prednisolone. The exposure is prescriptions of methylprednisolone or prednisolone tablets and the primary outcome is heart failure hospitalizations within the following 6 months, i.e. acute contacts with secondary or tertiary health care resulting in a primary diagnosis of heart failure. Secondary outcomes include broader heart failure diagnoses and the initiation of loop diuretics. Data preparation includes an initial observation period of 2 years, inclusion criteria such as age, corticosteroid formulation types / dosages and prescription codes, as well as removal of duplicate prescriptions and measures to reduce potential carry-over effects.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. An initial 2-year observational period, spanning from January 2008 to December 2009, will be used to establish comorbidities. Accordingly, only prescriptions of methylprednisolone or prednisolone dispensed from January 2010, onward, will be eligible for analyses.
✕. To minimize the risk of carry-over effects, we will exclude all prescriptions prescribed \< 6 months after another prescription for a corticosteroid. Accordingly, the same patient can contribute data on several treatment courses, provided that there was \> 6 months since the last prescription was dispensed (See section 7 for justification for why a 6-month interval was chosen).
✕. Duplicate prescriptions (same date, drug and dosage) will be kept in the analyses as a single treatment course. Cases of duplicate prescriptions on the same date, but where the drug or dosage is different will be excluded.
✕. Baseline of the treatment course will be defined as the date when the prescription of either methylprednisolone or prednisolone was dispensed.

What they're measuring

Acute heart failure

Timeframe: 6 months

Trial details

NCT IDNCT06468007

SponsorDiakonhjemmet Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-08-01

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