Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension
SAPHA
1 other identifier
interventional
32
1 country
1
Brief Summary
Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 2, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedOctober 23, 2012
October 1, 2012
2.3 years
March 2, 2011
October 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vascular phenotypes
(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)
16 weeks
Study Arms (1)
Amiloride
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Prehypertensive: Having systolic BP between 120 to 139 mmHg and/or diastolic BP between 80 to 89 mmHg during screening visit. BP will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. The average of last two BP measurements will be taken into consideration.
- Male or female of Caucasian or African-American origin.
- No history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.)
- Not taking any medication that affects blood pressure.
You may not qualify if:
- HbA1C \> 7.0 % during screening visit.
- Serum potassium \> 5.5 mEq/L during screening and/or any testing visit due to risk of developing hyperkalemia.
- Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 50 ml/min\* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction.
- Female having positive pregnancy test during screening and/or any testing visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgia Prevention Institute
Augusta, Georgia, 30912, United States
Related Publications (1)
Bhagatwala J, Harris RA, Parikh SJ, Zhu H, Huang Y, Kotak I, Seigler N, Pierce GL, Egan BM, Dong Y. Epithelial sodium channel inhibition by amiloride on blood pressure and cardiovascular disease risk in young prehypertensives. J Clin Hypertens (Greenwich). 2014 Jan;16(1):47-53. doi: 10.1111/jch.12218. Epub 2013 Oct 31.
PMID: 24410943DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Pediatrics
Study Record Dates
First Submitted
March 2, 2011
First Posted
March 4, 2011
Study Start
September 1, 2010
Primary Completion
December 1, 2012
Last Updated
October 23, 2012
Record last verified: 2012-10