B-type Natriuretic Peptide (BNP) in Human Hypertension
Stopped early · Phase 1
Conditions studied: Hypertension Stage 1
In brief
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 deficiency of the natriuretic peptides (NP). The remodeled hypertensive heart could result in altered processing and degradation of B-type NP resulting in altered molecular forms with decreased biological activity. The investigators further hypothesized the chronic administration of BNP in subjects with hypertension, is feasible, safe and will induce a sustained reduction in blood pressure.
Key facts
- Study ID
- NCT00953472
- Run by
- Mayo Clinic
- People needed
- 8
- Starts
- 2009-02-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2011-10-12
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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