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Spironolactone in Patients With Single Ventricle Heart

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ClinicalTrials.gov Identifier: NCT00211081
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : December 16, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University

Brief Summary:
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions. Using ultrasound we can see how arteries change with movement or even drugs. We want to use ultrasound to see how blood vessels look in patients with Congestive Heart Failure (CHF) and to also see how a drug called Spironolactone, commonly prescribed for patients with this disease, effects blood vessel function in patients with congestive heart failure. This information may be used to change the standard of care for patients with heart failure especially if we show that Spironolactone has a positive effect on vessel function in patients with CHF.

Condition or disease Intervention/treatment
Congenital Disorders Drug: Spironolactone (drug)

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Spironolactone on Endothelial Function in Patients With Single Ventricle Heart
Study Start Date : November 2004
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Open Label Drug: Spironolactone (drug)
1 mg/kg/day; afer 2 weeks doubled to 2/mg/kg/day. Patient's with endothelium-dependent brachial artery vasodilation and single-ventricle should show improvement within 4-8 weeks. Patients and their labs who are receiving Spironolactone will be followed.



Primary Outcome Measures :
  1. Change in Flow Mediated Dilation [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]
    Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.


Secondary Outcome Measures :
  1. C-Reactive Protein Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]
    The normal reference range for C-reactive protein is as follows: CRP: 0-10mg/L

  2. Interleukin-6 (IL-6) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]
    The normal result for IL-6 for Interleukin 6 is < 5pg/ml.

  3. Interleukin 1 Beta (IL1b) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]
    The normal result for IL1b is <3.9 pg/mL.

  4. Interleukin-10 (IL10) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]
    The normal result for IL-10 for Interleukin 10 is < 18pg/ml.

  5. Tumor Necrosis Factor-Alpha (TNF-a) Level [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]
    The normal result for TNF-a is <5.6 pg/mL.

  6. Change in 6 Minute Walk Test Score [ Time Frame: Baseline, Post-Intervention (4 Weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Single Ventricle Subjects
  • >17 years
  • have undergone Fontan Procedure

Exclusion Criteria:

  • History of smoking
  • Diabetes mellitus
  • Renal failure (serum creatinine > 2.5 mg/dl)
  • Recovering spironolactone for maintenance therapy
  • History of hyperkalemia (serum potassium> 5.5 mEq/L)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211081


Locations
United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: William T Mahle, MD Emory University
Principal Investigator: Arshed Quyyumi, MD Emory University
Principal Investigator: Wendy M Book, MD Emory University
Principal Investigator: Michael E McConnell, MD Emory University

Publications:
Responsible Party: William T. Mahle, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00211081     History of Changes
Other Study ID Numbers: 0954-2004
First Posted: September 21, 2005    Key Record Dates
Results First Posted: December 16, 2014
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by William T. Mahle, MD, Emory University:
Congenital Heart Disease
Spironolactone
>17 years old
undergone Fontan procedure
endothelial function

Additional relevant MeSH terms:
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents