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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Yanbin Dong, Georgia Health Sciences University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University Identifier:
First received: March 2, 2011
Last updated: October 22, 2012
Last verified: October 2012
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: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Yanbin Dong, Georgia Health Sciences University:

Primary Outcome Measures:
  • Vascular phenotypes [ Time Frame: 16 weeks ]
    (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


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01308983

Contact: Samip J Parikh, MBBS, MPH 7067211764

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yanbin Dong, Professor, Department of Pediatrics, Georgia Health Sciences University Identifier: NCT01308983     History of Changes
Other Study ID Numbers: 1000
Study First Received: March 2, 2011
Last Updated: October 22, 2012

Keywords provided by Yanbin Dong, Georgia Health Sciences University:
Flow mediated dilation
Pulse wave velocity
carotid compliance
Prehypertension and amiloride

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing processed this record on September 19, 2017