B-type Natriuretic Peptide (BNP) in Human Hypertension

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.