Status:
UNKNOWN
Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.
Lead Sponsor:
Rabin Medical Center
Conditions:
Heart Failure
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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 hospita...
Detailed Description
An Open-label randomized prospective study of HF patients (NYHA grade II-VI), hospitalized with COPD exacerbation. Eighty patients will be randomized in a 1:1 fashion to conventional and intervention ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02237820
Start Date
November 1 2014
End Date
June 1 2025
Last Update
April 6 2023
Active Locations (1)
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1
Beilinson Hospital, Rabin Medical Center
Petah Tikva, Israel, 49100