Comparing Dexamethasone and Prednisone for Heart Failure Patients with COPD Exacerbation

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

This study is testing whether dexamethasone works better than prednisone for heart failure patients who are in the hospital due to worsening COPD symptoms.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Rabin Medical Center (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Petah Tikva)
• Trial ID: NCT02237820 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of dexamethasone versus prednisone in heart failure patients who are hospitalized due to exacerbations of chronic obstructive pulmonary disease (COPD). It is an open-label, randomized, prospective trial involving 80 patients who will be assigned to receive either dexamethasone or prednisone during their hospital stay. The study aims to gather data on short-term outcomes and the potential benefits of using dexamethasone, which has less mineralocorticoid activity compared to prednisone. Patients will also receive standard treatments for COPD exacerbation as per established guidelines.

Who should consider this trial

Good fit: Ideal candidates are adults over 40 with a diagnosis of COPD and heart failure, specifically those experiencing exacerbations requiring hospitalization.

Not a fit: Patients with severe exacerbations or those on chronic mechanical ventilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for heart failure patients experiencing COPD exacerbations, potentially reducing hospital readmissions.

How similar studies have performed: While this approach is novel in this specific context, previous studies have shown varying success with glucocorticosteroids in managing COPD exacerbations.

Eligibility 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).

Where this trial is running

Petah Tikva

• Beilinson Hospital, Rabin Medical Center — Petah Tikva, Israel (Recruiting)

Study contacts

• Principal investigator: Gideon Y Stein, MD PhD — Beilinson Hospital, Rabin Medical Center
• Study coordinator: Alon Y Grossman, MD

Conditions Heart Failure; Chronic Obstructive Pulmonary Disease