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Spironolactone Safety in Dialysis Patients

Information source: State University of New York - Upstate Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Disease; Congestive Heart Failure

Intervention: spironolactone (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: State University of New York - Upstate Medical University

Official(s) and/or principal investigator(s):
Sriram S Narsipur, MD, Principal Investigator, Affiliation: State University of New York - Upstate Medical University

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: safety

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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


Last updated: June 3, 2013

Page last updated: August 23, 2015

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