Dose-comparison Study of Prednisone in Heart Failure

Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: prednisone; Drug: prednisone; Drug: prednisone

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
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shijiazhuang, China, 050031
    • The First Hospital Of Hebei Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050031
      • The First Hospital Of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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.; Drug: prednisone; 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 60 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 15 mg/day.; Drug: prednisone; 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 60 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 15 mg/day.; Drug: prednisone; 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 60 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily urinary volumes	Daily urinary volumes will be monitored for 10 days.	10 days
Urinary sodium excretion	Daily sodium exretions will be assessed at baseline, day 5 and day 10.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of prednisone on renin angiotensin aldosterone system.	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.	10 days

Collaborators and Investigators

• Sponsor: Hebei Medical University
• Investigators: Principal Investigator: Kunshen Liu, MD, The First Hospital Of Hebei Medical University

Publications and helpful links

General Publications

• Liu C, Zhao Q, Zhen Y, Zhai J, Liu G, Zheng M, Ma G, Wang L, Tian L, Ji L, Li L, Duan L, Liu K. Effect of Corticosteroid on Renal Water and Sodium Excretion in Symptomatic Heart Failure: Prednisone for Renal Function Improvement Evaluation Study. J Cardiovasc Pharmacol. 2015 Sep;66(3):316-22. doi: 10.1097/FJC.0000000000000282.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 21, 2012

Study Record Updates

• Last Update Posted (Estimate): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: heart failure; prednisone; diuresis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: GL-2011-29