Nesiritide in Resistant Hypertension

NCT01514357 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 11-001372UL1RR024150
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 kidney protection.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in Systolic Blood Pressure (BP)

  The change in BP with treatment over 7 days was assessed by the mean BP on admission, (treatment day 1) mean BP 23 hours after the first injection of BNP, and mean BP 23 hours after the second injection of BNP (treatment day 2). Treatment day 2 was 7 days after admission.

  baseline, treatment day 1, treatment day 2

Study Arms (2)

Nesiritide (BNP)

OTHER

Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.

Drug: Nesiritide (BNP)

Placebo

PLACEBO COMPARATOR

Subjects will receive SQ placebo bid for seven consecutive days.

Drug: Placebo

Interventions

Nesiritide (BNP) DRUG

NATRECOR® (nesiritide) is a sterile, purified preparation of human B-type natriuretic peptide (hBNP), and is manufactured from E. coli using recombinant DNA technology. Each 1.5 mg vial contains a white- to off-white lyophilized powder for intravenous (IV) administration after reconstitution.

Also known as: Natrecor

Nesiritide (BNP)

Placebo DRUG

Placebo will be administered subcutaneously instead of active drug (nesiritide) in a blind fashion in the second arm of the study.

Also known as: saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• John C Burnett: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Natriuretic Peptide, Brain; Saline Solution

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

This study was terminated early because the original principal investigator left the institution, and also due to the lack of funding.

Results Point of Contact

• Title: Dr. John C. Burnett
• Organization: Mayo Clinic

burnett.john@mayo.edu

507-284-7932

Study Officials

• John C Burnett, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Physiology

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 23, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 23, 2018
• Results First Posted: October 20, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)