Hemodynamic Effects of Spironolactone in Patients With Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

Hemodynamic Effects of Spironolactone in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860340
• Other study ID #: xMUO-02
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: December 9, 2014
• Start date: February 2003
• Est. completion date: October 2006

Study information

• Verified date: December 2014
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Spironolactone
100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.

Locations

Country	Name	City	State
United States	Medical University of Ohio	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiogram		3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug	No
Primary	Measure of Kidney function and potassium levels		This will be taken before drug, two hours after and the following day	No