Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension

NCT ID: NCT01308983

Last Updated: 2012-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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

Detailed Description

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Conditions

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Prehypertension

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amiloride

Group Type OTHER

Amiloride

Intervention Type DRUG

Amiloride 10 mg orally once a day for 16 weeks

Interventions

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Amiloride

Amiloride 10 mg orally once a day for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Yanbin Dong

Professor, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Georgia Prevention Institute

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Samip J Parikh, MBBS, MPH

Role: CONTACT

Phone: 7067211764

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 24410943 (View on PubMed)

Other Identifiers

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1000

Identifier Type: -

Identifier Source: org_study_id