Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is the first study assessing the impact of dexamethasone (a glucocorticosteroid with negligible mineralocorticoid activity) as compared to prednisone on short-term outcomes of HF patients hospitalized with exacerbation of COPD. The study may provide important data regarding a simple but potentially robust intervention among large patient population with high rates of hospital admissions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Prednisone

Criteria

Inclusion criteria:

• Age > 40 years.

• Patients with a previous diagnosis of COPD and evidence of airflow limitation (GOLD severity stage of II-IV).

• Patients with COPD exacerbation and potential indications for hospitalization as defined by the 2019 GOLD guidelines.

• Patients with a diagnosis of heart failure (NYHA grade II-IV).

Exclusion criteria:

• Patients with a severe exacerbation on enrollment, based upon arterial PH<7.2 or PaCO2 > 90 mmHg

• Patients who are currently participating in other studies.

• Known hypersensitivity to prednisone / dexamethasone.

• Patients who were treated with systemic corticosteroids one month prior to admission, unless prednisone dosage is 20 mg or less.

• Patients who are unable to provide an informed consent.

• Pregnant woman.

• Patients on Chronic mechanical ventilation.

Study drug treatment termination criteria:

• Hypersensitivity reaction to prednisone / dexamethasone.

• Any clinical deterioration, which at the discretion of the treating physician and/or study investigators, necessitate change of the study steroid treatment (such as, but not limited to, need to stop oral medication).