Prednisone for Decompensated Congestive Heart Failure

Sponsor

Hebei Medical University (Other)

Overall Status

Suspended

CT.gov ID

NCT00369044

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Drug: prednisone	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure

Study Start Date :

Oct 1, 2006

Anticipated Study Completion Date :

Jul 1, 2008

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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