Spironolactone Safety in Dialysis Patients

NCT00328809 | Withdrawn Phase 4

• 1 other identifier: 1045057
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• risk of hyperkalemia

  6 months

Study Arms (1)

Spirnolactone

EXPERIMENTAL

Drug: spironolactone

Interventions

spironolactone DRUG

spironolactone administered to ESRD patients at low dose

Spirnolactone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (1)

• Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

  PMID: 33586138 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Heart Failure

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sriram S Narsipur, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Pediatrics

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 22, 2006
• Study Start: June 30, 2013
• Primary Completion: June 30, 2017
• Study Completion: September 24, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)