Spironolactone Safety in Dialysis Patients

This study has been suspended.

( personnel shortage )

First Received on May 19, 2006. Last Updated on July 20, 2011 History of Changes

Sponsor:	State University of New York - Upstate Medical University
Information provided by:	State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:	NCT00328809

Purpose

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.

Condition	Intervention	Phase
End Stage Renal Disease Congestive Heart Failure	Drug: spironolactone	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Heart Failure Kidney Failure

Drug Information available for: Spironolactone

U.S. FDA Resources

Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:

safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
Active Comparator: Spirnolactone	Drug: spironolactone spironolactone administered to ESRD patients at low dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328809

Locations

United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210

Sponsors and Collaborators

State University of New York - Upstate Medical University

Investigators

Principal Investigator:

Sriram S Narsipur, MD

State University of New York - Upstate Medical University

More Information

No publications provided

Responsible Party:	Sriram S. Narsipur, MD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier:	NCT00328809 History of Changes
Other Study ID Numbers:	1045057
Study First Received:	May 19, 2006
Last Updated:	July 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Kidney Diseases
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Spironolactone

Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012