Back to resultsLeft Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease
Primary Purpose
Kidney Failure, Chronic
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Kidney Failure, Chronic, Hemodialysis, Spironolactone
Eligibility Criteria
Inclusion Criteria:
- hemodialysis patients
Exclusion Criteria:
- non compliance
- hyperkalemia
- pregnancy
- expected survival less than 9 months
Sites / Locations
- Allegheny General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1 group - no arms
Arm Description
no arm just error message
Outcomes
Primary Outcome Measures
Left ventricular mass
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00548912
Brief Title
Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease
Official Title
Cardiac Magnetic Resonance Imaging in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
study ended
Study Start Date
October 2007 (Actual)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dawnmarie DeFazio
4. Oversight
5. Study Description
Brief Summary
The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass
Detailed Description
Dialysis patients have significant morbidity and mortality associated with left ventricular hypertrophy and cardiac failure. Aldosterone may have an important role in the development of myocardial hypertrophy and remodeling. Animal studies have demonstrated beneficial effects of aldosterone antagonists on myocardial hypertrophy, and human studies have shown significant survival benefit in a non-dialysis population with congestive heart failure. This study evaluates the effect of spironolactone (an aldosterone receptor antagonist) on cardiac hypertrophy in the end-stage renal disease population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Kidney Failure, Chronic, Hemodialysis, Spironolactone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 group - no arms
Arm Type
Other
Arm Description
no arm just error message
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Primary Outcome Measure Information:
Title
Left ventricular mass
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hemodialysis patients
Exclusion Criteria:
non compliance
hyperkalemia
pregnancy
expected survival less than 9 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Marcus
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease
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