Status:
TERMINATED
Nesiritide in Resistant Hypertension
Lead Sponsor:
John C Burnett
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Hypothesis: If the use of B-type natriuretic peptide (BNP) is proven to be effective in controlling high blood pressure, it may lead to a reduction of standard therapy and improved cardiovascular and ...
Detailed Description
Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction, and heart failure. Its myocardial complications result from increased mechanical load on the he...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects with resistant hypertension as defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guidelines, systolic blood pressure and/or diastolic blood pressure \> 140/90 mm Hg. For patients with hypertension and diabetes or renal disease, blood pressure \> 130/80 mm Hg despite treatment with diuretic, sympathetic depressant and vasodilators.
- Medications may include a three drug regimen including:
- diuretic at therapeutic dose
- a second line agent such as sympatholytic (e.g. beta-blockade, central agent such as clonidine) or angiotensin converting enzyme inhibitor (ACEi) / angiotensin receptor blocker (ARB) or calcium channel blocker (CCB).
- third line agent including one of the above and/or direct vasodilator, such as hydralazine or minoxidil.
- Exclusion criteria:
- Congestive Heart Failure (any New York Heart Association (NYHA) class)
- Ejection Fraction \< 50%
- Known renal artery stenosis
- 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 ventricular tachycardia or ventricular fibrillation within 14 days of screening
- Sustained Atrial Fibrillation
- Second or third degree atrioventricular (AV) block without a permanent cardiac pacemaker
- Cerebral vascular accident within 3 months of screening, or other evidence of significantly compromised central nervous system perfusion
- Total bilirubin of \> 1.5 mg/dL or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5 times the upper limit of normal range
- Renal insufficiency assessed by calculated Glomerular Filtration Rate (GFR) \< 30 ml/min (Cockcroft-Gault equation)
- Serum sodium of \< 125 milliequivalent (mEq)/dL or \> 160 mEq/dL
- Serum potassium of \< 3.0 mEq/dL or \> 5.5 mEq/dL
- Women taking hormonal contraceptives
- Pregnancy
- Body mass index (BMI) \> 35
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01514357
Start Date
April 1 2012
End Date
July 1 2014
Last Update
March 23 2018
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905