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

Sponsor

Rabin Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02237820

Collaborator

(none)

Enrollment

Location

Arms

103

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Chronic Obstructive Pulmonary Disease	Drug: Dexamethasone Drug: Prednisone	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone	Drug: Dexamethasone 6 mg/day of Oral Dexamethasone
Active Comparator: Prednisone	Drug: Prednisone 40 mg/day of Oral Prednisone

Arm

Intervention/Treatment

Experimental: Dexamethasone

Drug: Dexamethasone

6 mg/day of Oral Dexamethasone

Active Comparator: Prednisone

Drug: Prednisone

40 mg/day of Oral Prednisone

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Rate of re-admission [30 days post enrollment]
rate of respiratory deterioration necessitate intubation, re-admission or death at 30-day post enrollment

Other Outcome Measures

Change from Baseline in diuretic doses [Baseline, Week 2, Week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beilinson Hospital, Rabin Medical Center	Petah Tikva		Israel	49100

Sponsors and Collaborators

Rabin Medical Center

Investigators

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