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

Augusta University

Status and phase: Unknown; Phase 4

Conditions: Prehypertension

Treatments: Drug: Amiloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01308983

1000

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Amiloride

Other group

Treatment:

Drug: Amiloride