Prednisone for Decompensated Congestive Heart Failure

Phase 2

Suspended

• Conditions: Heart Failure, Congestive

• Registration Number: NCT00369044
• Lead Sponsor: Hebei Medical University

Brief Summary

We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.

Detailed Description

Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.

Study Timeline

• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Study First Posted: 2006-08-29
• Study Start: 2006-10
• Status Verified: 2007-06
• Study Completion: 2008-07
• Last Update Submitted: 2009-04-07
• Last Update Posted: 2009-04-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Hospitalized with primary diagnosis of CHF

• Patients with normal cortical function

• LVEF <40%

• Significant fluid overload, defined as ≥ 2 of the following

  • Enlarged liver or ascites
  • Peripheral or sacral edema ( ≥ 2+)
  • Jugular venous distention ≥ 10 cm
  • Pulmonary rales, pleural effusion on chest x-ray or orthopnea

Exclusion Criteria

• Severe stenotic valvular disease
• Serum creatinine > 4 mg/dl
• Patient refusal
• Any signs of infection or any condition that would contraindicate an glucocorticoids use
• Poor controlled hypertension
• Poor controlled diabetes mellitus
• Active myocarditis
• Malignancy or other terminal illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2

Secondary Outcome Measures

Name	Time	Method
Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile

Trial Locations

Locations (1)

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China