Spironolactone in Patients With Single Ventricle Heart

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00211081
First received: September 13, 2005
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 Intervention
Congenital Disorders
Drug: Spironolactone (drug)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Spironolactone on Endothelial Function in Patients With Single Ventricle Heart

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • change in flow mediated dilation (during reactive hyperemia); evaluate endothelial function at baseline and 4-5 weeks after initial study. [ Time Frame: 4-5 weeks after initial study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in BNP [ Time Frame: drawn at baseline and 4-5 week visit ] [ Designated as safety issue: No ]
  • change in Form assay [ Time Frame: drawn at baseline and 4-5 week visit ] [ Designated as safety issue: No ]
  • change in TNF alpha [ Time Frame: drawn at baseline and 4-5 week visit ] [ Designated as safety issue: No ]
  • change in cytotkine panels [ Time Frame: drawn at baseline and 4-5 week visit ] [ Designated as safety issue: No ]
  • change in 6 minute walk test [ Time Frame: performed at first and last visit to determine toleration of daily activity ] [ Designated as safety issue: No ]
  • drawn and conducted at baseline and 4-5 weeks after initial study. [ Time Frame: baseline and 4-5 weeks after initial study ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: November 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: William T. Mahle, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00211081     History of Changes
Other Study ID Numbers: 0954-2004
Study First Received: September 13, 2005
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014