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Spironolactone Safety in Dialysis Patients
This study has been suspended.
( personnel shortage )
Study NCT00328809   Information provided by State University of New York - Upstate Medical University
First Received: May 19, 2006   Last Updated: June 8, 2009   History of Changes

May 19, 2006
June 8, 2009
 
 
 
 
Complete list of historical versions of study NCT00328809 on ClinicalTrials.gov Archive Site
 
 
 
Spironolactone Safety in Dialysis Patients
Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone

Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.

 
Phase IV
Interventional
Treatment, Open Label, Uncontrolled, Crossover Assignment, Safety Study
  • End Stage Renal Disease
  • Congestive Heart Failure
Drug: spironolactone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
 
 
 

Inclusion Criteria:

  • They must be at least 18 years of age.
  • They must understand the study purpose and give their written informed consent.
  • They must have been stable on chronic hemodialysis for at least three months before enrollment into the study.
  • Hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. A repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction.

Exclusion Criteria:

  • Subjects with primary operable valvular heart disease.
  • Subjects with a congenital heart disease.
  • Subjects with unstable angina.
  • Subjects with primary hepatic failure.
  • Subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease).
  • Subjects who have undergone heart transplantation or who are awaiting heart transplantation are also ineligible.
  • Subjects on a renal transplant list will be accepted into the study until the time of successful renal transplantation and termination of dialysis.
  • Subjects with habitually difficult to control hyperkalemia (serum potassium >6.0 meq/L) in the previous month while on dialysis will be excluded.
  • The inability to complete the 6-minute walk test will not be a reason to exclude subjects from this study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00328809
Sriram S. Narsipur, MD, SUNY Upstate Medical University
1045057
State University of New York - Upstate Medical University
 
Principal Investigator: Sriram S Narsipur, MD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP