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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone treatment group | 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. |
| |
| Prednisolone treatment group | Patients receiving 5 mg or 20 mg prednisolone tablets for any of the following conditions: Pulmonary, Rheumatology and musculoskeletal; Neurology and ophthalmology; Dermatology; Endocrinology and metabolic; Gastrointestinal; Hematology and immunology; Nephrology. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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This registry-based study will include data from the nationwide Norwegian Cardio-Rheuma Registry (NCRR) that encompasses the entire Norwegian adult population over a ten-year period from January 2008 to December 2017.
Individual participant data will not be made available to other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2024 | Oct 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
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 |
Analyses of all primary and secondary outcomes including only individuals with existing heart failure or established atherosclerotic cardiovascular disease
| 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:
| 6 months |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |