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NCT Number: NCT06468007

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

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.

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Key information

Conditions

Heart Failure; With Decompensation Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Individuals aged < 18 years in January 2008 will be excluded
  • Analyses will be restricted to tablets, as prednisolone is only available in this form.
  • To allow for equipotent dose comparisons, we will focus only on 4 mg and 16 mg methylprednisolone and their counterparts in prednisolone at 5 mg and 20 mg, respectively. Patients with other doses will be excluded.
  • To facilitate comparisons of treatments prescribed for similar conditions, we will only include prescriptions with an International Classification of Diseases, 10th Edition (ICD10) or International Classification of Primary Care, 2nd Edition (ICPC2) refund code.
  • Patients with prescriptions for diagnosis codes including palliative care, cancer symptoms, medical complications, and organ transplants will be excluded. This exclusion aims to reduce the inherent heterogeneity within these groups, allowing for a more comparable baseline risk.
  • 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.

Treatment and study plan

Methylprednisolone Tablet

Drug

Patients receiving equipotent doses of methylprednisolone or prednisolone . Dosages will be determined at the discretion of the treating physician, customized for the specific clinical need in accordance with local guidelines.

Other names: Prednisolone Tablet

Primary outcomes

  1. Acute heart failure

    Time frame: 6 months

    Acute hospital contact (secondary or tertiary healthcare facilities) where the patient was given a primary diagnosis code for heart failure (ICD10 code i50*) at discharge (dead or alive).

Secondary outcomes

  1. Any heart failure diagnosis, acute or elective

    Time frame: 6 months

    Any contact (acute or elective) with secondary or tertiary healthcare facilities where a primary diagnosis of heart failure is recorded

  2. Newly prescribed loop diuretics or any increase in doses

    Time frame: 6 months

    Initiation of newly prescribed loop diuretics or any increase in doses of loop diuretics

  3. A combination of outcome 2 and 3

    Time frame: 6 months

    ny contact (acute or elective) with secondary or tertiary healthcare facilities where a primary diagnosis of heart failure is recorded, and / or initiation of newly prescribed loop diuretics or any increase in doses of loop diuretics.

Other outcomes

  1. Only individuals with existing heart failure

    Time frame: 6 months

    Analyses of all primary and secondary outcomes including only individuals with existing heart failure

  2. Only individuals with existing heart failure or atherosclerotic cardiovascular disease

    Time frame: 6 months

    Analyses of all primary and secondary outcomes including only individuals with existing heart failure or established atherosclerotic cardiovascular disease

  3. Only individuals with at least 3 comorbidities

    Time frame: 6 months

    Analyses of all primary and secondary outcomes including only individuals with at least three of the following:

    • Atherosclerotic cardiovascular disease (coronary, cerebral and peripheral artery disease)
    • Chronic kidney disease
    • Diabetes (type 1 and 2)
    • Hypertension
    • Heart failure
    • Chronic obstructive pulmonary disease
    • Use of lipid-lowering drugs

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Official study title

SAP Version 28 May 2024. Comparative Effects of Methylprednisolone and Prednisolone on the Risk of Acute Decompensated Heart Failure - An Emulated Target Trial

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jun 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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