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

April 5, 2023 updated by: Gideon Stein, md, Rabin Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alon Y Grossman, MD
  • Phone Number: 972-3-9376606
  • Email: ALONG@gmail.com

Study Contact Backup

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • Recruiting
        • Beilinson Hospital, Rabin medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: up to 1 month
up to 1 month
Change in COPD assessment tool (CAT) questionnaire score
Time Frame: Baseline, Week 2, Week 4
Baseline, Week 2, Week 4
Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12 short form) score
Time Frame: Baseline, Week 2, Week 4
Baseline, Week 2, Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of re-admission
Time Frame: 30 days post enrollment
rate of respiratory deterioration necessitate intubation, re-admission or death at 30-day post enrollment
30 days post enrollment

Other Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in diuretic doses
Time Frame: Baseline, Week 2, Week 4
Baseline, Week 2, Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • no specific protocol ID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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