Spironolactone in Patients With Single Ventricle Heart - Full Text View

Sponsor:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00211081

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:

Drug Information available for: Spironolactone

U.S. FDA Resources

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:

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

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:

Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5.

Sorensen KE, Celermajer DS, Spiegelhalter DJ, Georgakopoulos D, Robinson J, Thomas O, Deanfield JE. Non-invasive measurement of human endothelium dependent arterial responses: accuracy and reproducibility. Br Heart J. 1995 Sep;74(3):247-53.

Celermajer DS. Endothelial dysfunction: does it matter? Is it reversible? J Am Coll Cardiol. 1997 Aug;30(2):325-33. Review.

Celermajer DS, Sorensen K, Ryalls M, Robinson J, Thomas O, Leonard JV, Deanfield JE. Impaired endothelial function occurs in the systemic arteries of children with homozygous homocystinuria but not in their heterozygous parents. J Am Coll Cardiol. 1993 Sep;22(3):854-8.

Anderson TJ, Elstein E, Haber H, Charbonneau F. Comparative study of ACE-inhibition, angiotensin II antagonism, and calcium channel blockade on flow-mediated vasodilation in patients with coronary disease (BANFF study) J Am Coll Cardiol. 2000 Jan;35(1):60-6.

Gidding SS, Rocchini AP, Moorehead C, Schork MA, Rosenthal A. Increased forearm vascular reactivity in patients with hypertension after repair of coarctation. Circulation. 1985 Mar;71(3):495-9.

Yang SG, Rychik J. Mesenteric blood flow patterns: A link to protein-losing enteropathy after the Fontan operation. Circulation 1999;100-18:A3583.

Responsible Party:	Chairman, Emory University Institutional Review Board
ClinicalTrials.gov Identifier:	NCT00211081 History of Changes
Other Study ID Numbers:	954-2004
Study First Received:	September 13, 2005
Last Updated:	July 2, 2008
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
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012