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Congestive Heart FailurePhase 1/2SubqBNPNCT00252187

Cardiac Hormone Replacement With Brain Natriuretic Peptide (BNP) in Heart Failure

A Phase 1/2 study testing B-type Natriuretic Peptide (BNP) in people with Congestive Heart Failure and Cardiomyopathy, run by Horng Chen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effects of subcutaneous injection of Human BNP (nesiritide), a hormone produced by the heart, on the pumping ability of the heart, kidney function, and hormonal function in persons with heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure, Cardiomyopathy
What is being tested?
B-type Natriuretic Peptide (BNP)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteUnited States
Study dates
Jan 2000to Jun 2010
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years
  • Resting left ventricular ejection fraction (LVEF) of 35% or less (determined within 48 months of recruitment by echocardiography, multiple gate acquisition scan (MUGA) or left ventriculogram.)
  • New York Heart Association (NYHA) Class I (with previous symptoms of heart failure), Class II and III
  • Female subjects not menopausal or surgically sterilized will need to have a negative pregnancy test the day before the study day and be on contraception.

Who cannot join

  • Myocardial infarction (MI) within 3 months of screening.
  • Unstable angina within 14 days of screening, or any evidence of myocardial ischemia.
  • Valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.
  • Sustained ventricular tachycardia (VT) or ventricular fibrillation (V-fib) within 14 days of screening.
  • Second or third degree atrioventricular (AV) block without a permanent cardiac pacemaker.
  • Cerebrovascular accident (CVA) within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion.
Show all 21Show fewer
  • Serum creatinine of >3.0 mg/dL.
  • Serum sodium of <125 milliequivalents per decaLiter (mEq/dL) or > 160 mEq/dL.
  • Serum potassium of < 3.5 mEq/dL or > 5.2 mEq/dL.
  • Serum digoxin level of > 2.0 ng/ml.
  • Systolic pressure of <85 mmHg immediately prior to the first injection of study drug/placebo.
  • LVEF > 35% by within 24 months of screening.
  • Unable to self-administer subcutaneous injection twice a day.
  • Diagnosed with AIDS or known positive HIV titer.
  • Other acute or chronic medical conditions or laboratory abnormality, which may increase the risks, associated with study participation or may interfere with interpretation of the data.
  • Received an investigational drug within 1 month prior to dosing.
  • Unable to undergo cardiac magnetic resonance imaging (MRI). Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips, or severe claustrophobia.
  • In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.
  • Patient in atrial fibrillation or who have a pacemaker or implantable cardioverter defibrillator (ICD)
  • Hemoglobin < 10g/dl.
  • Patients with an allergy to iodine.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Cardiac Hormone Replacement With BNP in Heart Failure: A Novel Therapeutic Strategy

The purpose of this study is to determine the effects of subcutaneous injection of Human BNP (nesiritide), a hormone produced by the heart, on the pumping ability of the heart, kidney function, and hormonal function in persons with heart failure.

Read the detailed description

The cardiac hormone brain natriuretic peptide (BNP) plays an important role in the pathophysiology of congestive heart failure (CHF). Studies have established that BNP mediates natriuresis, renin and aldosterone (RAAS) inhibition, vasodilation and lusitropism. Acute cardiac hormone replacement with intravenous infusion of BNP has been shown to possess potent vasodilating actions in humans with acute decompensated CHF resulting in improvement of clinical symptoms. Natrecor (nesiritide) a sterile, purified preparation of human BNP is approved by the FDA for intravenous administration in the treatment of patients with acute decompensated congestive heart failure. However, chronic cardiac hormone replacement with BNP as therapeutic strategy in CHF has been limited by the need to administer BNP intravenously. The objective of this study is to define the cardiorenal and humoral actions of short term (eight weeks) chronic cardiac hormone replacement with subcutaneous (SQ) BNP in human NYHA class II-III CHF. Systolic and diastolic function, left ventricular remodeling as assessed by its volume, renal function, neurohumoral profiling and exercise capacity will be assessed prior to and after eight weeks of treatment.

Being tested
B-type Natriuretic Peptide (BNP), Placebo
Keywords
Heart failure, Natriuretic peptides, B-type natriuretic peptide, Kidney, Nesiritide, Natrecor, CHF
Medical subject headings
Heart Failure, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B-type Natriuretic Peptide (BNP)Drug

    Also called Nesiritide

    BNP hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.

  • PlaceboOther

    Placebo self-administered subcutaneously twice daily for 8 weeks.

Study groups in NCT00252187
Study groupRoleWhat they receive
B-type Natriuretic Peptide (BNP)Active comparatorBNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
Receives: Drug: B-type Natriuretic Peptide (BNP)
PlaceboPlacebo comparatorPlacebo self-administered subcutaneously twice daily for 8 weeks.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Left Ventricular (LV) Volume Index at 8 Weeks

    LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.

    Measured: Baseline and 8 weeks

  2. Change in Left Ventricular (LV) Mass Index at 8 Weeks

    Measured: Baseline and 8 weeks

Secondary outcomes (6)

  1. Change in Left Ventricular (LV) Filling Pressure at 8 Weeks

    Filling pressure determined by ratio of E/e' [Echocardiograph Doppler mitral inflow velocity (E) to mitral annulus tissue Doppler velocity (e') ratio]

    Measured: Baseline and 8 weeks

  2. Change in Plasma Renin Activity at 8 Weeks

    Plasma renin is synthesized within circulation or at tissue sites, causing vasoconstriction or vasodilation.

    Measured: Baseline and 8 weeks

  3. Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks

    Kidney function was measured by GFR determined by iothalamate clearance. Glomerular filtration rate describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body-surface area. A lower GFR means the kidney is not filtering normally.

    Measured: Baseline and 8 weeks

  4. Change in Heart Rate at 8 Weeks

    Heart rate was measured when MRI was performed

    Measured: Baseline and 8 weeks

  5. Change in Blood Pressure at 8 Weeks

    Blood pressure was measured during the MRI

    Measured: Baseline and 8 weeks

  6. Change in Left Ventricular Ejection Fraction at 8 Weeks

    Left Ventricle Ejection Fraction (LVEF)is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a measure of the amount of blood pumped out of the lower chamber (ventricle) of the heart during a heartbeat, measured by Magnetic Resonance Imaging (MRI).

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2005 (estimated)
  2. Study startJan 2000
  3. Primary completionJul 2008
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252187
Sponsor's protocol ID
69-00
Other IDs
R01HL036634, R01HL084155, P01HL076611, UL1RR024150
Acronym
SubqBNP
Status last verified
Dec 2012
First submitted
10 Nov 2005
Last updated
20 Dec 2012
Data monitoring committee
Yes

Publications

  • Chen HH, Glockner JF, Schirger JA, Cataliotti A, Redfield MM, Burnett JC Jr. Novel protein therapeutics for systolic heart failure: chronic subcutaneous B-type natriuretic peptide. J Am Coll Cardiol. 2012 Dec 4;60(22):2305-12. doi: 10.1016/j.jacc.2012.07.056. Epub 2012 Nov 1.

    PubMed 23122795

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing B-type Natriuretic Peptide (BNP) in people with Congestive Heart Failure and Cardiomyopathy, run by Horng Chen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Left Ventricular (LV) Volume Index at 8 Weeks (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00252187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.

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