Text Size

Spironolactone Safety in Dialysis Patients

This study has suspended participant recruitment.
(personnel shortage)
Sponsor:
Information provided by (Responsible Party):
Sri Narsipur, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00328809
First received: May 19, 2006
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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 4

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:

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: Sri Narsipur, Associate Professor of Medicine and Pediatrics, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00328809     History of Changes
Other Study ID Numbers: 1045057
Study First Received: May 19, 2006
Last Updated: December 11, 2012
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 May 16, 2013