Heart FailurePhase 4NCT02237820
Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.
A Phase 4 study testing Dexamethasone and Prednisone in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Dexamethasone and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Beilinson Hospital, Rabin Medical Center
Petah Tikva, 49100
Gideon Y Stein, MD PhD, 972-3-9376606, gidi.stein@gmail.com
Ran Nissan, PharmD, 972-54-4892333, rnissan5@gmail.com
About this study
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.
Read the 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 testament groups. Informed consent will be obtained from all patients prior to study enrolment.
Randomization will be performed using RED cap - secure web application. The conventional therapy group will receive 40mg of oral prednisone daily, while the intervention group will be treated with oral dexamethasone in an equivalent anti-inflammatory dose of 6 mg/day. Glucocorticosteroids will be administered throughout hospitalization and will be continued for at least 5-7 days. Dose changes through this period, as well as subsequent tapering will be on the discretion of the treating physician. All patients will also be treated with short-acting bronchodilators, antibiotics, oxygen, positive pressure non-invasive mechanical ventilation and VTE prophylaxis - based on the GOLD 2019 guidelines and clinical judgment of the attending physicians. An order for low sodium diet will be written. Discharge decisions will be based on the GOLD 2019 discharge criteria list. Patients will be discharge without steroid tapering regimen unless indicated by clinical judgment. Patient's demographic data will be documented at baseline (age, sex, GOLD severity stage, data on hospitalizations in the past year, patients' chronic drug therapy, Last spirometry and two-dimensional echo-Doppler examination results).
On admission, patients' weight, height and oxygen saturation will be measured and routine blood tests will be drawn for evaluation of complete blood count, chemistry, NT proBNP levels, troponin, C-reactive protein and venous blood gas. Blood test results will be taken from the patient electronic medical record and will be based on the tests taken in the ER and during ward admission. Upon recruitment, the patient will be asked to complete COPD assessment tool (CAT) questionnaire and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12, the short form version) in order to quantify their health status. A follow-up telephone call visit will be performed 14±2 and 28±2 days after enrollment. The following measures will be obtained: KCCQ-12 and CAT questionnaire scores and documentation of current diuretic dose. After study completion, each patient will be followed for 30 more days post admission in order to document further hospitalizations.
All the date collected during the study and after patients enrollment will be documented on a specialized case report form (CRF) built on RED cap - secure web application.
- Being tested
- Dexamethasone, Prednisone
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
6 mg/day of Oral Dexamethasone
PrednisoneDrug
40 mg/day of Oral Prednisone
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
| Prednisone | Active comparator | Not described Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: up to 1 month
Change in COPD assessment tool (CAT) questionnaire score
Measured: Baseline, Week 2, Week 4
Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12 short form) score
Measured: Baseline, Week 2, Week 4
Secondary outcomes (1)
Rate of re-admission
rate of respiratory deterioration necessitate intubation, re-admission or death at 30-day post enrollment
Measured: 30 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gideon Stein, md, Rabin Medical Center
- Investigators
- Gideon Y Stein, MD PhD, Principal investigator, Beilinson Hospital, Rabin Medical CenterRan Nissan, PharmD, Study director, Beilinson Hospital, Rabin Medical CenterLisa Cooper, MD, Study director, Beilinson Hospital, Rabin Medical CenterMordechai R Kramer, MD, Principal investigator, Beilinson Hospital, Rabin Medical CenterShmuel Fuchs, MD, Principal investigator, Beilinson Hospital, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237820
- Sponsor's protocol ID
- no specific protocol ID
- Status last verified
- Apr 2023
- First submitted
- 9 Sep 2014
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19168510Iversen 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.
PubMed 18537871Iversen 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.
PubMed 20395261Schweiger 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.
PubMed 20554591Maxwell CB, Jenkins AT. Drug-induced heart failure. Am J Health Syst Pharm. 2011 Oct 1;68(19):1791-804. doi: 10.2146/ajhp100637.
PubMed 21930637Wei 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.
PubMed 15545676Global Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2013.
Gardner D, Shoback D. Greenspan's basic & clinical endocrinology, 9 edition. McGraw-Hill Companies, Inc.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT02237820
- Acronym / sponsor ID
- no specific protocol ID
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 testament groups. Informed consent will be obtained from all patients prior to study enrolment.
Randomization will be performed using RED cap - secure web application. The conventional therapy group will receive 40mg of oral prednisone daily, while the intervention group will be treated with oral dexamethasone in an equivalent anti-inflammatory dose of 6 mg/day. Glucocorticosteroids will be administered throughout hospitalization and will be continued for at least 5-7 days. Dose changes through this period, as well as subsequent tapering will be on the discretion of the treating physician. All patients will also be treated with short-acting bronchodilators, antibiotics, oxygen, positive pressure non-invasive mechanical ventilation and VTE prophylaxis - based on the GOLD 2019 guidelines and clinical judgment of the attending physicians. An order for low sodium diet will be written. Discharge decisions will be based on the GOLD 2019 discharge criteria list. Patients will be discharge without steroid tapering regimen unless indicated by clinical judgment. Patient's demographic data will be documented at baseline (age, sex, GOLD severity stage, data on hospitalizations in the past year, patients' chronic drug therapy, Last spirometry and two-dimensional echo-Doppler examination results).
On admission, patients' weight, height and oxygen saturation will be measured and routine blood tests will be drawn for evaluation of complete blood count, chemistry, NT proBNP levels, troponin, C-reactive protein and venous blood gas. Blood test results will be taken from the patient electronic medical record and will be based on the tests taken in the ER and during ward admission. Upon recruitment, the patient will be asked to complete COPD assessment tool (CAT) questionnaire and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12, the short form version) in order to quantify their health status. A follow-up telephone call visit will be performed 14±2 and 28±2 days after enrollment. The following measures will be obtained: KCCQ-12 and CAT questionnaire scores and documentation of current diuretic dose. After study completion, each patient will be followed for 30 more days post admission in order to document further hospitalizations.
All the date collected during the study and after patients enrollment will be documented on a specialized case report form (CRF) built on RED cap - secure web application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone |
| Prednisone | Active comparator | Drug: Prednisone |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone6 mg/day of Oral Dexamethasone | Drug | Dexamethasone |
| Prednisone40 mg/day of Oral Prednisone | Drug | Prednisone |
Primary outcome
Length of hospital stay
Time frame: up to 1 month
Change in COPD assessment tool (CAT) questionnaire score
Time frame: Baseline, Week 2, Week 4
Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12 short form) score
Time frame: Baseline, Week 2, Week 4
1 secondary outcome
Rate of re-admission
Time frame: 30 days post enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 19168510Hawkins 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.
- Background: PubMed 18537871Iversen 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.
- Background: PubMed 20395261Iversen 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.
- Background: PubMed 20554591Schweiger 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.
- Background: PubMed 21930637Maxwell CB, Jenkins AT. Drug-induced heart failure. Am J Health Syst Pharm. 2011 Oct 1;68(19):1791-804. doi: 10.2146/ajhp100637.
- Background: PubMed 15545676Wei 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.
- BackgroundGlobal Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2013.
- BackgroundGardner D, Shoback D. Greenspan's basic & clinical endocrinology, 9 edition. McGraw-Hill Companies, Inc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gideon Y Stein, MD PhD principal investigator
Beilinson Hospital, Rabin Medical Center
Ran Nissan, PharmD study director
Beilinson Hospital, Rabin Medical Center
Lisa Cooper, MD study director
Beilinson Hospital, Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Prednisone in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Y Grossman, MD (972-3-9376606, ALONG@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237820, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.