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Spironolactone Safety in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT00328809
Recruitment Status : Withdrawn (personnel shortage)
First Posted : May 22, 2006
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Sri Narsipur, State University of New York - Upstate Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Congestive Heart Failure Drug: spironolactone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Estimated Study Start Date : June 30, 2013
Estimated Primary Completion Date : June 30, 2017
Actual Study Completion Date : September 24, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Spirnolactone Drug: spironolactone
spironolactone administered to ESRD patients at low dose


Outcome Measures
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Primary Outcome Measures :
  1. risk of hyperkalemia [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328809


Locations
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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
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Principal Investigator: Sriram S Narsipur, MD State University of New York - Upstate Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sri Narsipur, Associate Professor of Medicine and Pediatrics, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00328809    
Other Study ID Numbers: 1045057
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Heart Failure
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
 Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents