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Dose-comparison Study of Prednisone in Heart Failure

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ClinicalTrials.gov Identifier: NCT01559727
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Kun-shen Liu M.D., Hebei Medical University

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Drug: prednisone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
Study Start Date : March 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Daily urinary volumes [ Time Frame: 10 days ]
    Daily urinary volumes will be monitored for 10 days.

  2. Urinary sodium excretion [ Time Frame: 10 days ]
    Daily sodium exretions will be assessed at baseline, day 5 and day 10.


Secondary Outcome Measures :
  1. The effect of prednisone on renin angiotensin aldosterone system. [ Time Frame: 10 days ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 The First Hospital of Hebei Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by Kun-shen Liu M.D., Hebei Medical University:
heart failure
diuresis
prednisone

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