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

NCT06468007 | Completed

• 1 other identifier: SAP version 28 May 2024.
• Study Type: observational
• Target: 12,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; With Decompensation

Keywords

Methylprednisolone; Prednisolone; Emulated target trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Any heart failure diagnosis, acute or elective

  6 months

• Newly prescribed loop diuretics or any increase in doses

  6 months

• A combination of outcome 2 and 3

  6 months

Other Outcomes (3)

• Only individuals with existing heart failure

  6 months

• Only individuals with existing heart failure or atherosclerotic cardiovascular disease

  6 months

• Only individuals with at least 3 comorbidities

  6 months

Study Arms (2)

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.

Drug: Methylprednisolone Tablet

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.

Interventions

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.

Also known as: Prednisolone Tablet

Methylprednisolone treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

1. Individuals aged \< 18 years in January 2008 will be excluded 2. Analyses will be restricted to tablets, as prednisolone is only available in this form. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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). 8. 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. 9. Baseline of the treatment course will be defined as the date when the prescription of either methylprednisolone or prednisolone was dispensed.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Methylprednisolone; Prednisolone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 21, 2024
• Study Start: January 1, 2010
• Primary Completion: August 1, 2017
• Study Completion: December 31, 2017
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share