Prednisone for Decompensated Congestive Heart Failure

Hebei Medical University

Status and phase: Suspended; Phase 3; Phase 2

Conditions: Heart Failure, Congestive

Treatments: Drug: prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00369044

200608A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind