Back to resultsHemodynamic Effects of Spironolactone in Patients With Heart Failure
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Hemodynamics, Echocardiographs
Eligibility Criteria
Inclusion Criteria:
- CHF
- 21 - 80 years
- Serum creatinine < 2 mg/dL
- Serum potassium 2.7 - 4.5 mg/dL measured within past 4 weeks
Exclusion Criteria:
- Less than 21 years
- Pregnancy
Sites / Locations
- Medical University of Ohio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Study patient will take 100mg tablet of Spironolactone
Outcomes
Primary Outcome Measures
Echocardiogram
Measure of Kidney function and potassium levels
Secondary Outcome Measures
Full Information
NCT ID
NCT00860340
First Posted
March 11, 2009
Last Updated
December 9, 2014
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT00860340
Brief Title
Hemodynamic Effects of Spironolactone in Patients With Heart Failure
Official Title
Hemodynamic Effects of Spironolactone in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action.
Randomized, two group placebo controlled, single blind study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive Heart Failure, Hemodynamics, Echocardiographs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Study patient will take 100mg tablet of Spironolactone
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.
Primary Outcome Measure Information:
Title
Echocardiogram
Time Frame
3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug
Title
Measure of Kidney function and potassium levels
Time Frame
This will be taken before drug, two hours after and the following day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CHF
21 - 80 years
Serum creatinine < 2 mg/dL
Serum potassium 2.7 - 4.5 mg/dL measured within past 4 weeks
Exclusion Criteria:
Less than 21 years
Pregnancy
Facility Information:
Facility Name
Medical University of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Effects of Spironolactone in Patients With Heart Failure
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