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Spironolactone in Patients With Single Ventricle Heart

This study has been completed.
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University Identifier:
First received: September 13, 2005
Last updated: December 8, 2014
Last verified: December 2014
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
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

Resource links provided by NLM:

Further study details as provided by William T. Mahle, MD, Emory University:

Primary Outcome Measures:
  • Change in Flow Mediated Dilation [ Time Frame: Baseline, 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:
  • Change in BNP [ Time Frame: drawn at baseline and 4-5 week visit ]
  • Change in Form Assay [ Time Frame: drawn at baseline and 4-5 week visit ]
  • Change in TNF Alpha [ Time Frame: drawn at baseline and 4-5 week visit ]
  • Change in Cytotkine Panels [ Time Frame: drawn at baseline and 4-5 week visit ]
  • Change in 6 Minute Walk Test [ Time Frame: performed at first and last visit to determine toleration of daily activity ]
  • Drawn and Conducted at Baseline and 4-5 Weeks After Initial Study. [ Time Frame: baseline and 4-5 weeks after initial study ]

Enrollment: 12
Study Start Date: November 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description


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

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 identifier: NCT00211081

United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
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

Responsible Party: William T. Mahle, MD, Principal Investigator, Emory University Identifier: NCT00211081     History of Changes
Other Study ID Numbers: 0954-2004
Study First Received: September 13, 2005
Results First Received: December 8, 2014
Last Updated: December 8, 2014

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

Additional relevant MeSH terms:
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on September 19, 2017