NCT00405548

Brief Summary

The purpose of this research study is to evaluate the effects of cardiac hormone replacement with SQ (subcutaneous or under the skin) injection of BNP (brain natriuretic peptide, a hormone produced by the heart) on the pumping ability of the heart, kidney function and levels of different hormones in the blood in response to an intravenous salt solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 9, 2014

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

3.1 years

First QC Date

November 29, 2006

Results QC Date

April 8, 2014

Last Update Submit

June 3, 2015

Conditions

Left Ventricular Diastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in Urinary Sodium Excretion in Response to Saline Load

    Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).

    Baseline, 12 weeks

Secondary Outcomes (3)

  • Change in Urinary Flow in Response to Saline Load

    Baseline, 12 weeks

  • Change in Glomerular Filtration Rate (GFR) in Response to Saline Load

    Baseline, 12 weeks

  • Left Ventricular (LV) Filling Pressure

    Baseline, 12 weeks

Study Arms (2)

BNP (nesiritide)

ACTIVE COMPARATOR

BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks

Drug: BNP (nesiritide)

Placebo

PLACEBO COMPARATOR

Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)

Drug: Placebo

Interventions

BNP (nesiritide)DRUG
Also known as: natrecor, nesiritide
BNP (nesiritide)
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by Doppler echocardiography
  • No signs or symptoms of congestive heart failure and who have not been hospitalized for heart failure

You may not qualify if:

  • Myocardial Infarction (MI) within 3 months of screening
  • Unstable angina within 14 days of screening, or any evidence of myocardial ischemia
  • Significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
  • Severe congenital heart diseases
  • Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
  • Second or third degree heart block without a permanent cardiac pacemaker
  • Stroke within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion
  • Total bilirubin of \> 1.5 mg/dL or other liver enzymes \> 1.5 times the upper limit of normal (mg/dL = milligrams per deciliter)
  • Serum creatinine of \> 3.0 mg/dL
  • Serum sodium of \< 125 mEq/dL or \> 160 mEq/dL (milliequivalents per deciliter)
  • Serum potassium of \< 3.5 mEq/dL or \> 5.0/dL
  • Serum digoxin level of \> 2.0 ng/ml (nanograms per milliliter)
  • Systolic pressure of \< 85 mm Hg (millimeters of mercury)
  • Hemoglobin \< 10 gm/dl (grams per deciliter)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Wan SH, McKie PM, Schirger JA, Slusser JP, Hodge DO, Redfield MM, Burnett JC Jr, Chen HH. Chronic Peptide Therapy With B-Type Natriuretic Peptide in Patients With Pre-Clinical Diastolic Dysfunction (Stage B Heart Failure). JACC Heart Fail. 2016 Jul;4(7):539-547. doi: 10.1016/j.jchf.2015.12.014. Epub 2016 Feb 10.

    PMID: 26874387DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Dr. Horng H. Chen
Organization
Mayo Clinic
chen.horng@mayo.edu
507-538-2354

Study Officials

  • Horng H. Chen, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Horng H Chen

Study Record Dates

First Submitted

November 29, 2006

First Posted

November 30, 2006

Study Start

March 1, 2008

Primary Completion

April 1, 2011

Study Completion

August 1, 2012

Last Updated

July 1, 2015

Results First Posted

May 9, 2014

Record last verified: 2015-06

Locations

US(1)