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

Primary Purpose

Prehypertension

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Amiloride

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring Prehypertension, Flow mediated dilation, Pulse wave velocity, carotid compliance, Prehypertension and amiloride

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts 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.

Sites / Locations

Georgia Prevention InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Amiloride

Arm Description

Outcomes

Primary Outcome Measures

Vascular phenotypes

(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)

Secondary Outcome Measures

Full Information

NCT ID

NCT01308983

First Posted

March 2, 2011

Last Updated

October 22, 2012

Sponsor

Augusta University

1. Study Identification

Unique Protocol Identification Number

NCT01308983

Brief Title

Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension

Acronym

SAPHA

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prehypertension

Keywords

Prehypertension, Flow mediated dilation, Pulse wave velocity, carotid compliance, Prehypertension and amiloride

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amiloride

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Amiloride

Intervention Description

Amiloride 10 mg orally once a day for 16 weeks

Primary Outcome Measure Information:

Title

Vascular phenotypes

Description

(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Samip J Parikh, MBBS, MPH

Phone

7067211764

sparikh@georgiahealth.edu

Facility Information:

Facility Name

Georgia Prevention Institute

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanbin Dong, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24410943

Citation

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.

Results Reference

derived

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Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension

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