Dose-comparison Study of Prednisone in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kun-shen Liu M.D., Hebei Medical University
ClinicalTrials.gov Identifier:
NCT01559727
First received: March 19, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.


Condition Intervention Phase
Heart Failure
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure

Resource links provided by NLM:


Further study details as provided by Hebei Medical University:

Primary Outcome Measures:
  • Daily urinary volumes [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Daily urinary volumes will be monitored for 10 days.

  • Urinary sodium excretion [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Daily sodium exretions will be assessed at baseline, day 5 and day 10.


Secondary Outcome Measures:
  • The effect of prednisone on renin angiotensin aldosterone system. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    The effect of prednisone on patients' renin angiotensin aldosterone system, such as renin activity, plasma Ang I, plasma Ang II, and plasma aldosterone will be will be assessed on baseline, day 5 and day 10.


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
The patients with symptomatic heart failure were treated with standard treatment.
Experimental: 15 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
Drug: prednisone
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
Experimental: 30 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day.
Drug: prednisone
The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day
Experimental: 60 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day.
Drug: prednisone
The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day

Detailed Description:

Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hospitalized for symptomatic heart failure
  • dyspnea at rest or with minimal activity
  • NT-proBNP > 1000pg/ml
  • LVEF ≤ 40%

Exclusion Criteria:

  • any condition (other than CHF) that could limit the use of prednisone;
  • acute decompensated heart failure
  • active myocarditis
  • obstructive or restrictive cardiomyopathy
  • cardiac surgery within previous 3 months
  • acute coronary syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559727

Locations
China, Hebei
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
China
The First Hospital of Hebei Medical University
Shijiazhuang, China, 050031
Sponsors and Collaborators
Hebei Medical University
Investigators
Principal Investigator: Kunshen Liu, MD Hebei Medical University First Hospital
  More Information

No publications provided

Responsible Party: Kun-shen Liu M.D., Professor, Hebei Medical University
ClinicalTrials.gov Identifier: NCT01559727     History of Changes
Other Study ID Numbers: GL-2011-29
Study First Received: March 19, 2012
Last Updated: August 27, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Hebei Medical University:
heart failure
diuresis
prednisone

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014