B-type Natriuretic Peptide (BNP) in Human Hypertension

NCT00953472 | Terminated Phase 1 DMC

• 2 other identifiers: 06-003032MC cardiorenal lab funds
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension Stage 1

Keywords

hypertension treatment

Outcome Measures

Primary Outcomes (1)

• The blood pressure will decrease with BNP injections

  during study intervention

Interventions

brain natriuretic peptide DRUG

start 10 mcg/kg (2 participants), 7 mcg/kg (2 participants), 5 mcg/kg (2 participants) and 2 mcg/kg (2 participants)

no-added salt diet OTHER

instruction to reduce salt for one week prior to study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: August 6, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)