Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension (SAPHA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Georgia Regents University
Sponsor:
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01308983
First received: March 2, 2011
Last updated: October 22, 2012
Last verified: October 2012

March 2, 2011
October 22, 2012
September 2010
December 2012   (final data collection date for primary outcome measure)
Vascular phenotypes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)
Same as current
Complete list of historical versions of study NCT01308983 on ClinicalTrials.gov Archive Site
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Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension
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Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prehypertension
Drug: Amiloride
Amiloride 10 mg orally once a day for 16 weeks
Amiloride
Intervention: Drug: Amiloride
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years to 35 Years
Yes
Contact: Samip J Parikh, MBBS, MPH 7067211764 sparikh@georgiahealth.edu
United States
 
NCT01308983
1000
Yes
Yanbin Dong, Georgia Health Sciences University
Georgia Regents University
Not Provided
Not Provided
Georgia Regents University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP