B-type Natriuretic Peptide (BNP) in Human Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00953472
Recruitment Status : Terminated
First Posted : August 6, 2009
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Hypertension Stage 1 Drug: brain natriuretic peptide Other: no-added salt diet Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Proteomics and Protein Therapeutics in Human Hypertension (BNP in Human Hypertension - Phase 1)
Study Start Date : February 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Intervention Details:
  • Drug: brain natriuretic peptide
    start 10 mcg/kg (2 participants), 7 mcg/kg (2 participants), 5 mcg/kg (2 participants) and 2 mcg/kg (2 participants)
  • Other: no-added salt diet
    instruction to reduce salt for one week prior to study

Primary Outcome Measures :
  1. The blood pressure will decrease with BNP injections [ Time Frame: during study intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00953472

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic

Responsible Party: Mayo Clinic Identifier: NCT00953472     History of Changes
Other Study ID Numbers: 06-003032
MC cardiorenal lab funds
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Mayo Clinic:
hypertension treatment

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs