NCT00211081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

December 16, 2014

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

3.6 years

First QC Date

September 13, 2005

Results QC Date

December 8, 2014

Last Update Submit

October 3, 2017

Conditions

Congenital Disorders

Keywords

Congenital Heart DiseaseSpironolactone>17 years oldundergone Fontan procedureendothelial function

Outcome Measures

Primary Outcomes (1)

  • Change in Flow Mediated Dilation

    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.

    Baseline, Post-Intervention (4 Weeks)

Secondary Outcomes (6)

  • C-Reactive Protein Level

    Baseline, Post-Intervention (4 Weeks)

  • Interleukin-6 (IL-6) Level

    Baseline, Post-Intervention (4 Weeks)

  • Interleukin 1 Beta (IL1b) Level

    Baseline, Post-Intervention (4 Weeks)

  • Interleukin-10 (IL10) Level

    Baseline, Post-Intervention (4 Weeks)

  • Tumor Necrosis Factor-Alpha (TNF-a) Level

    Baseline, Post-Intervention (4 Weeks)

  • +1 more secondary outcomes

Study Arms (1)

Open Label

EXPERIMENTAL
Drug: Spironolactone (drug)

Interventions

Spironolactone (drug)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.

Open Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Related Publications (7)

  • 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. doi: 10.1016/0140-6736(92)93147-f.

    PMID: 1359209BACKGROUND

  • 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. doi: 10.1136/hrt.74.3.247.

    PMID: 7547018BACKGROUND

  • Celermajer DS. Endothelial dysfunction: does it matter? Is it reversible? J Am Coll Cardiol. 1997 Aug;30(2):325-33. doi: 10.1016/s0735-1097(97)00189-7.

    PMID: 9247501BACKGROUND

  • 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. doi: 10.1016/0735-1097(93)90203-d.

    PMID: 8354824BACKGROUND

  • 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. doi: 10.1016/s0735-1097(99)00537-9.

    PMID: 10636260BACKGROUND

  • 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. doi: 10.1161/01.cir.71.3.495.

    PMID: 3971523BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Defects, Congenital

Interventions

SpironolactonePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Willam Mahle
Organization
Emory University
wmahle@emory.edu
404-785-6000

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 6, 2017

Results First Posted

December 16, 2014

Record last verified: 2017-10

Locations

US(1)