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B-type Natriuretic Peptide (BNP) in Human Hypertension

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00953472
First received: April 2, 2009
Last updated: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Hypertension Stage 1
 Drug: brain natriuretic peptide
Other: no-added salt diet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Proteomics and Protein Therapeutics in Human Hypertension (BNP in Human Hypertension - Phase 1)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The blood pressure will decrease with BNP injections [ Time Frame: during study intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: February 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953472

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00953472     History of Changes
Other Study ID Numbers: 06-003032, MC cardiorenal lab funds
Study First Received: April 2, 2009
Last Updated: October 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
hypertension treatment

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013