Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211081
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2005-09-13
Brief Title:
Spironolactone in Patients With Single Ventricle Heart
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Impact of Spironolactone on Endothelial Function in Patients With Single Ventricle Heart
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Spironolactone The starting dose of spironolactone is 1 mgkgday After two weeks this dose will be doubled to the same maximum dose 2mgkgday as in RALES If side effects occur or plasma urea and electrolytes became deranged the dose will be halved Patients unable to tolerate the minimum dose will be withdrawn Measurement of serum electrolytes will occur at baseline at two weeks and at time of repeat evaluation
Endothelial Function
Subjects with single ventricle will have an evaluation of endothelial function
1 At baseline
2 On spironolactone- 4-5 weeks after initial study
Imaging protocol
The diameter of the brachial artery will be measured from two-dimensional ultrasound images using a 12 MHz linear array transducer and an Accuson Sequoia system Accuson Mountainview California Measurements of the brachial artery will be obtained
1 In a resting state
2 During limb ischemia
3 In response to reactive hyperemia
4 At rest
Reactive hyperemia will be induced by inflating a standard blood pressure cuff to 50 mm Hg above the systolic blood pressure for 45 minutes and then deflating the cuff
After data collection the DICOM-formatted images will be transferred to a PC for investigator-blinded measurement of brachial artery diameter using image analysis software Brachial Tools 31 Medical Imaging Applications Iowa
Measurement of prognostic markers
Blood samples
Plasma beta-type natriuretic peptide form assay TNF alpha and a Cytokine panel will be drawn at base line and at the final 4-5 week visit for this study
Samples will be collected between 11 am and 1 pm after 30 minutes supine rest The samples will be centrifuged and plasma stored at -70C peptides or -20C other samples Plasma beta-type natriuretic peptide BNP samples will be collected into EDTA and aprotonin and measured by radioimmunoassay 6-minute walk test
A 6-minute walk test will be performed at the first visit and the last visit During this test signs and symptoms will be recorded ie chest pain and shortness of breath to determine toleration of daily activity A doctor or nurse will conduct this test and the patient will be provided the opportunity to stop or rest if symptoms become severe
Outcome measures
The primary outcome measure will be the change in flow mediated dilation during reactive hyperemia This will be expressed as a percentage
Secondary outcome measures will include changes in BNP Form assay TNF alpha Cytokine panels and the 6-minute walk test
Statistical analysis
We and others have previously shown that asymptomatic patients with the Fontan operation have a mean flow-mediated dilation of approximately 4 compared to 8-9 in controls In order to detect a 25 change in FMD with a power of 080 the current study would require a patient population of 13 cases There are currently over 40 patients with single ventricle who are followed in the adult congenital clinic at Emory University
We plan on enrolling 20 patients into this study
Endothelial Function
Subjects with single ventricle will have an evaluation of endothelial function
1 At baseline
2 On spironolactone- 4-5 weeks after initial study
Imaging protocol
The diameter of the brachial artery will be measured from two-dimensional ultrasound images using a 12 MHz linear array transducer and an Accuson Sequoia system Accuson Mountainview California Measurements of the brachial artery will be obtained
1 In a resting state
2 During limb ischemia
3 In response to reactive hyperemia
4 At rest
Reactive hyperemia will be induced by inflating a standard blood pressure cuff to 50 mm Hg above the systolic blood pressure for 45 minutes and then deflating the cuff
After data collection the DICOM-formatted images will be transferred to a PC for investigator-blinded measurement of brachial artery diameter using image analysis software Brachial Tools 31 Medical Imaging Applications Iowa
Measurement of prognostic markers
Blood samples
Plasma beta-type natriuretic peptide form assay TNF alpha and a Cytokine panel will be drawn at base line and at the final 4-5 week visit for this study
Samples will be collected between 11 am and 1 pm after 30 minutes supine rest The samples will be centrifuged and plasma stored at -70C peptides or -20C other samples Plasma beta-type natriuretic peptide BNP samples will be collected into EDTA and aprotonin and measured by radioimmunoassay 6-minute walk test
A 6-minute walk test will be performed at the first visit and the last visit During this test signs and symptoms will be recorded ie chest pain and shortness of breath to determine toleration of daily activity A doctor or nurse will conduct this test and the patient will be provided the opportunity to stop or rest if symptoms become severe
Outcome measures
The primary outcome measure will be the change in flow mediated dilation during reactive hyperemia This will be expressed as a percentage
Secondary outcome measures will include changes in BNP Form assay TNF alpha Cytokine panels and the 6-minute walk test
Statistical analysis
We and others have previously shown that asymptomatic patients with the Fontan operation have a mean flow-mediated dilation of approximately 4 compared to 8-9 in controls In order to detect a 25 change in FMD with a power of 080 the current study would require a patient population of 13 cases There are currently over 40 patients with single ventricle who are followed in the adult congenital clinic at Emory University
We plan on enrolling 20 patients into this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None