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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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


Condition Intervention Phase
Prehypertension
 Drug: Amiloride
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Vascular phenotypes [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    (Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)


Estimated Enrollment: 32
Study Start Date: September 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amiloride Drug: Amiloride
Amiloride 10 mg orally once a day for 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308983

Contacts
Contact: Samip J Parikh, MBBS, MPH 7067211764 sparikh@georgiahealth.edu

Locations
United States, Georgia
Georgia Prevention Institute Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Yanbin Dong, MD, PhD            
Sponsors and Collaborators
Georgia Regents University
  More Information

No publications provided

Responsible Party: Yanbin Dong, Professor, Department of Pediatrics, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01308983     History of Changes
Other Study ID Numbers: 1000
Study First Received: March 2, 2011
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
Prehypertension
Flow mediated dilation
Pulse wave velocity
carotid compliance
Prehypertension and amiloride

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013