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Completed

NCT Number: NCT01559727

Dose-comparison Study of Prednisone in Heart Failure

The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

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About this study

Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hospitalized for symptomatic heart failure
  • dyspnea at rest or with minimal activity
  • NT-proBNP > 1000pg/ml
  • LVEF ≤ 40%

Exclusion criteria

  • any condition (other than CHF) that could limit the use of prednisone;
  • acute decompensated heart failure
  • active myocarditis
  • obstructive or restrictive cardiomyopathy
  • cardiac surgery within previous 3 months
  • acute coronary syndrome

Treatment and study plan

Prednisone

Drug

The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.

Primary outcomes

  1. Daily urinary volumes

    Time frame: 10 days

    Daily urinary volumes will be monitored for 10 days.

  2. Urinary sodium excretion

    Time frame: 10 days

    Daily sodium exretions will be assessed at baseline, day 5 and day 10.

Secondary outcomes

  1. The effect of prednisone on renin angiotensin aldosterone system.

    Time frame: 10 days

    The effect of prednisone on patients' renin angiotensin aldosterone system, such as renin activity, plasma Ang I, plasma Ang II, and plasma aldosterone will be will be assessed on baseline, day 5 and day 10.

Sponsors and collaborators

Lead sponsor

Hebei Medical University

Other

Registry information

Official study title

Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2012
Registry last updated
Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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