Prednisone for Decompensated Congestive Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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prednisone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No