Status:
TERMINATED
B-type Natriuretic Peptide (BNP) in Human Hypertension
Lead Sponsor:
Mayo Clinic
Conditions:
Hypertension Stage 1
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The investigators working hypothesis is that human hypertension is in part due to a derangement in the endocrine function of the heart - a primary or secondary mechanism - resulting in a relative defi...
Detailed Description
Ongoing investigations by our laboratory group and others have established that the heart is an endocrine organ as well as a pump. The heart synthesizes and secretes two peptide hormones - atrial natr...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Subjects with stage 1 hypertension (SBP: 140-159 mm Hg or DBP 90-99 mm Hg) If on therapy, it must be stable for at least 1 month.
Exclusion
- Congestive Heart Failure (any NYHA class).
- EF \< 50%.
- Myocardial infarction within 3 months of screening.
- Unstable angina within 14 days of screening, or any evidence of myocardial ischemia.
- Moderate to severe pulmonary hypertension.
- Valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.
- Sustained VT or V-fib within 14 days of screening.
- Sustained Atrial Fibrillation.
- Second or third degree AV block without a permanent cardiac pacemaker.
- CVA within 3 months of screening, or other evidence of significantly compromised CNS perfusion.
- Total bilirubin of \>1.5 mg/dL or AST and ALT 1.5 times the upper limit of normal range.
- Renal insufficiency assessed by calculated GFR \< 60 ml/min (Cockroft-Gault equation).
- Serum sodium of \< 125 mEq/dL or \> 160 mEq/dL.
- Serum potassium of \< 3.5 mEq/dL or \> 5.0 mEq/dL.
- Women taking hormonal contraceptives.
- Body Mass Index (BMI) \> 35.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00953472
Start Date
February 1 2009
End Date
April 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905