Comparative Effects of Methylprednisolone and Prednisolone on the Risk of Acute Decompensated Heart Failure - An Emulated Target Trial
NCT Number: NCT06468007
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Heart Failure; With Decompensation
Interventions: DRUG: Methylprednisolone Tablet
Sponsor: Diakonhjemmet Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-01-01
Completion Date: 2017-12-31

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.

Primary Outcome Measures: Acute heart failure, 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)., 6 months
Secondary Outcome Measures: Any heart failure diagnosis, acute or elective, Any contact (acute or elective) with secondary or tertiary healthcare facilities where a primary diagnosis of heart failure is recorded, 6 months|Newly prescribed loop diuretics or any increase in doses, Initiation of newly prescribed loop diuretics or any increase in doses of loop diuretics, 6 months|A combination of outcome 2 and 3, 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., 6 months
Other Outcome Measures: Only individuals with existing heart failure, Analyses of all primary and secondary outcomes including only individuals with existing heart failure, 6 months|Only individuals with existing heart failure or atherosclerotic cardiovascular disease, Analyses of all primary and secondary outcomes including only individuals with existing heart failure or established atherosclerotic cardiovascular disease, 6 months|Only individuals with loop diuretic prescriptions, Analyses of all primary and secondary outcomes including only individuals with loop diuretic prescriptions, 6 months|Only individuals with at least 3 comorbidities, 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, 6 months