Spironolactone Safety in Dialysis Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 19, 2006

Last Updated Date

January 25, 2008

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00328809 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Spironolactone Safety in Dialysis Patients

Official Title ^†

Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Randomized, Double-Blind, Placebo Control, Crossover Assignment

Condition ^†

End Stage Renal Disease
Congestive Heart Failure

Intervention ^†

Drug: spironolactone

Study Arms / Comparison Groups

Publications *

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

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Sriram S Narsipur, MD

3154645290

fagana@upstate.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00328809

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

State University of New York - Upstate Medical University

Collaborators ^††

Investigators ^†

Principal Investigator:

Sriram S Narsipur, MD

State University of New York - Upstate Medical University

Information Provided By

State University of New York - Upstate Medical University

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.