Heart Failure, Congestive
Conditions
Keywords
decompensated heart failure, prednisone, diuretics, diuresis
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.
Interventions
DRUGprednisone
Sponsors
Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile | — |
Countries
China
Outcome results
None listed