Comparative Effects of Methylprednisolone and Prednisolone on the Risk of Acute Decompensated Heart Failure - An Emulated Target Trial
- Registration Number
- NCT06468007
- Lead Sponsor
- Diakonhjemmet Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Methylprednisolone treatment group Methylprednisolone Tablet Patients receiving 4 mg or 16 mg methylprednisolone tablets for any of the following conditions: Pulmonary, Rheumatology and musculoskeletal; Neurology and ophthalmology; Dermatology; Endocrinology and metabolic; Gastrointestinal; Hematology and immunology; Nephrology.
- Primary Outcome Measures
Name Time Method Acute heart failure 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 Outcome Measures
Name Time Method Newly prescribed loop diuretics or any increase in doses 6 months Initiation of newly prescribed loop diuretics or any increase in doses of loop diuretics
A combination of outcome 2 and 3 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.
Any heart failure diagnosis, acute or elective 6 months Any contact (acute or elective) with secondary or tertiary healthcare facilities where a primary diagnosis of heart failure is recorded