Status:
COMPLETED
Effects of Tetrahydrobiopterin on Blood Pressure
Lead Sponsor:
Emory University
Collaborating Sponsors:
American Heart Association
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
Tetrahydrobiopterin (BH4) is a cofactor for the nitric oxide (NO) synthase enzymes, such that its insufficiency results in uncoupling of the enzyme, leading to release of superoxide rather than NO in ...
Detailed Description
Problem of Interest: Blood vessels are lined by a single layer of cells called the endothelium. These cells actively release substances that influence a variety of functions including blood flow in t...
Eligibility Criteria
Inclusion
- Male or female patients without childbearing potential between the ages of 18 and 75 years
- History of documented essential hypertension or newly diagnosed hypertension (BP \>140 mmHg systolic and/or 90 mmHg diastolic measured on 2 separate occasions)
- Patients on conventional anti-hypertensive therapy with poorly controlled hypertension (BP \>135/85 mmHg). Their anti-hypertensive regimen will remain unchanged throughout the study period. Patients will not need to stop taking their prescribed anti-hypertensives.
- Controls will be recruited for part 2 of the study. These will be patients who meet the age and childbearing criteria above, who have no history of hypertension, arterial BP of \<130 systolic and \<85 diastolic, no evidence of diabetes mellitus, total cholesterol \<240 and be non-smoking for at least six months.
- Patients can be at any stage of hypertension. They can be at any performance status. The only requirement will be that they be able to come to scheduled follow up visits either by themselves or with assistance. Patients will need to be able to give informed consent.
Exclusion
- Female subjects with childbearing potential.
- History of symptomatic coronary or peripheral vascular disease.
- Known secondary causes for hypertension
- Severe uncontrolled hypertension (BP \>180 mmHg systolic and /or 110 mmHg diastolic).
- Severe co-morbid conditions which would limit life expectancy to less than 6 months.
- Patients unable to give informed consent or adhere to the protocol.
- Patients participating in another study protocol.
- Patients with organ failure, creatinine \>2.5 mg/dL or hepatic enzymes \>2X normal
- Recent (within 6 weeks) alteration of any concomitant therapy.
- Presence of intercurrent illness
- Bleeding disorders
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00208780
Start Date
December 1 2004
End Date
December 1 2005
Last Update
November 18 2013
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322