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

Heart Failure; With Decompensation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06468007
• Other study ID #: SAP version 28 May 2024.
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2024
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: December 31, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

Drug:
• Methylprednisolone Tablet
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Only individuals with existing heart failure	Analyses of all primary and secondary outcomes including only individuals with existing heart failure	6 months
Other	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
Other	Only individuals with loop diuretic prescriptions	Analyses of all primary and secondary outcomes including only individuals with loop diuretic prescriptions	6 months
Other	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
Primary	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	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
Secondary	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
Secondary	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