Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.
1 other identifier
interventional
80
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 heart-failure
Started Nov 2014
Longer than P75 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 6, 2023
April 1, 2023
10.5 years
September 9, 2014
April 5, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Length of hospital stay
up to 1 month
Change in COPD assessment tool (CAT) questionnaire score
Baseline, Week 2, Week 4
Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12 short form) score
Baseline, Week 2, Week 4
Secondary Outcomes (1)
Rate of re-admission
30 days post enrollment
Other Outcomes (1)
Change from Baseline in diuretic doses
Baseline, Week 2, Week 4
Study Arms (2)
Dexamethasone
EXPERIMENTALPrednisone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beilinson Hospital, Rabin Medical Center
Petah Tikva, 49100, Israel
Related Publications (8)
Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJ. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009 Feb;11(2):130-9. doi: 10.1093/eurjhf/hfn013.
PMID: 19168510BACKGROUNDIversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS-Lung Function Study Group. Chronic obstructive pulmonary disease in patients admitted with heart failure. J Intern Med. 2008 Oct;264(4):361-9. doi: 10.1111/j.1365-2796.2008.01975.x. Epub 2008 Jun 5.
PMID: 18537871BACKGROUNDIversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS Lung Function Study Group. The prognostic importance of lung function in patients admitted with heart failure. Eur J Heart Fail. 2010 Jul;12(7):685-91. doi: 10.1093/eurjhf/hfq050. Epub 2010 Apr 15.
PMID: 20395261BACKGROUNDSchweiger TA, Zdanowicz M. Systemic corticosteroids in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Am J Health Syst Pharm. 2010 Jul 1;67(13):1061-9. doi: 10.2146/ajhp090293.
PMID: 20554591BACKGROUNDMaxwell CB, Jenkins AT. Drug-induced heart failure. Am J Health Syst Pharm. 2011 Oct 1;68(19):1791-804. doi: 10.2146/ajhp100637.
PMID: 21930637BACKGROUNDWei L, MacDonald TM, Walker BR. Taking glucocorticoids by prescription is associated with subsequent cardiovascular disease. Ann Intern Med. 2004 Nov 16;141(10):764-70. doi: 10.7326/0003-4819-141-10-200411160-00007.
PMID: 15545676BACKGROUNDGlobal Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2013.
BACKGROUNDGardner D, Shoback D. Greenspan's basic & clinical endocrinology, 9 edition. McGraw-Hill Companies, Inc.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gideon Y Stein, MD PhD
Beilinson Hospital, Rabin Medical Center
- STUDY DIRECTOR
Ran Nissan, PharmD
Beilinson Hospital, Rabin Medical Center
- STUDY DIRECTOR
Lisa Cooper, MD
Beilinson Hospital, Rabin Medical Center
- PRINCIPAL INVESTIGATOR
Mordechai R Kramer, MD
Beilinson Hospital, Rabin Medical Center
- PRINCIPAL INVESTIGATOR
Shmuel Fuchs, MD
Beilinson Hospital, Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD , PhD
Study Record Dates
First Submitted
September 9, 2014
First Posted
September 11, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2025
Study Completion
June 1, 2025
Last Updated
April 6, 2023
Record last verified: 2023-04