NCT00369044

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 8, 2009

Status Verified

June 1, 2007

First QC Date

August 28, 2006

Last Update Submit

April 7, 2009

Conditions

Heart Failure, Congestive

Keywords

decompensated heart failureprednisonediureticsdiuresis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Interventions

prednisoneDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

Related Publications (1)

  • Liu C, Chen H, Zhou C, Ji Z, Liu G, Gao Y, Tian L, Yao L, Zheng Y, Zhao Q, Liu K. Potent potentiating diuretic effects of prednisone in congestive heart failure. J Cardiovasc Pharmacol. 2006 Oct;48(4):173-6. doi: 10.1097/01.fjc.0000245242.57088.5b.

    PMID: 17086096BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kunshen Liu, MD

    The First Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 29, 2006

Study Start

October 1, 2006

Study Completion

July 1, 2008

Last Updated

April 8, 2009

Record last verified: 2007-06

Locations

CN(1)