Back to resultsB-type Natriuretic Peptide (BNP) in Human Hypertension
Primary Purpose
Hypertension Stage 1
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
brain natriuretic peptide
no-added salt diet
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension Stage 1 focused on measuring hypertension treatment
Eligibility 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.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
The blood pressure will decrease with BNP injections
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00953472
Brief Title
B-type Natriuretic Peptide (BNP) in Human Hypertension
Official Title
Clinical Proteomics and Protein Therapeutics in Human Hypertension (BNP in Human Hypertension - Phase 1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) - that are endogenous ligands for a particulate guanylyl cyclase receptor (NPR-A). Following receptor binding and generation of its second messenger cGMP, the natriuretic peptides (NPs) mediate biological actions which include natriuresis, inhibition of the renin-angiotensin system and vasodilatation with local autocrine and paracrine actions in the heart to include inhibition of fibrosis and enhancement of diastolic function.
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 heart. Under physiological conditions of increased myocardial load and resulting myocardial stretch, ANP and BNP synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood pressure homeostasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension Stage 1
Keywords
hypertension treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
brain natriuretic peptide
Intervention Description
start 10 mcg/kg (2 participants), 7 mcg/kg (2 participants), 5 mcg/kg (2 participants) and 2 mcg/kg (2 participants)
Intervention Type
Other
Intervention Name(s)
no-added salt diet
Intervention Description
instruction to reduce salt for one week prior to study
Primary Outcome Measure Information:
Title
The blood pressure will decrease with BNP injections
Time Frame
during study intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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B-type Natriuretic Peptide (BNP) in Human Hypertension
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