Hemodynamic Effects of Spironolactone in Patients With Heart Failure

December 9, 2014 updated by: University of Toledo Health Science Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Study patient will take 100mg tablet of Spironolactone
Drug: Spironolactone
100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Echocardiogram
Time Frame: 3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug
3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug
Measure of Kidney function and potassium levels
Time Frame: This will be taken before drug, two hours after and the following day
This will be taken before drug, two hours after and the following day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toledo Health Science Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (ESTIMATE)

March 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xMUO-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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