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

Sponsor

Augusta University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01308983

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.

Condition or Disease	Intervention/Treatment	Phase
Prehypertension	Drug: Amiloride	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Amiloride	Drug: Amiloride Amiloride 10 mg orally once a day for 16 weeks

Arm

Intervention/Treatment

Other: Amiloride

Drug: Amiloride

Amiloride 10 mg orally once a day for 16 weeks

Outcome Measures

Primary Outcome Measures

Vascular phenotypes [16 weeks]
(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.