Human BNP (Nesiritide) to Help Heart, Kidney, and Hormonal Functions in Persons With Lower Heart Pumping Function - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Institutes of Health (NIH)
Information provided by (Responsible Party):	Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00405639

Purpose

The following are done for screening procedures to determine if patients are eligible for this study: blood count, kidney and liver blood tests. Patients will complete a 6-minute walk test. Patients will be instructed to follow a no-added-salt diet for 1-3 weeks before the study and for the whole duration of the study. Diet instructions will be given to the patient and the patient will collect his/her urine for 24 hours before the active study day. Patients will need to avoid strenuous exercise and abstain from smoking, alcohol, and caffeine for 3 days prior to the study days. Patients will remain on their regular medications. Please read the detailed description for more information.

Condition	Intervention	Phase
Heart Failure- Asymptomatic Systolic Dysfunction	Drug: Human BNP Natrecor	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
Official Title:	To Define in Human Preclinical Systolic Dysfunction (PSD) the Actions of Chronic Administration of Subcutaneous (SQ) BNP on the Left Ventricular, Renal, and Humoral Function and on the Integrated Response to Acute Sodium Loading

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Nesiritide

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To define in human PSD the actions of chronic administration of SQ BNP on left ventricular, renal, and humoral function and on the integrated response to acute sodium loading [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chronic peptide therapy with SQ BNP in subjects with PSD will reverse left ventricular remodeling as compared to placebo as evident by reduced left atrium volume, improved diastolic relaxation, decreased E/e ratio, reduction of plasma procollagen [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Chronic peptide therapy with SQ BNP in subjects with PSD will improve renal function by increased sodium excretion, GFR, and effective renal plasma flow in response to acute sodium loading as compared to the response of placebo-treated subjects. [ Time Frame: 5 ] [ Designated as safety issue: No ]
4. Chronic peptide therapy with SQ BNP in subjects with PSD will improve humoral function with suppression of the renin-angiotensin-aldosterone system, cardiotrophin I, endothelin I and catecholamines as compared to placebo. [ Time Frame: 5 ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	June 2006
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Pre-systolic group	Drug: Human BNP Natrecor 33 subjects will be randomized to SQ BNP and 17 will be randomized to control group Other Name: (nesiritide)

Detailed Description:

Participants in this study will be randomized to receive BNP or placebo (an inactive, saline shot). The participant will need to give themselves a shot in their stomach (similar to diabetics giving themselves insulin) twice a day for twelve weeks. The study requires a screening visit at the Charlton Building to determine eligibility and discuss the study. At this visit a blood draw for heart and liver function and a six minute walk will be done. There will also be two other outpatient visits and two inpatient stays, for 48 hours, in the General Clinical Research Center (GCRC) at St. Marys Hospital. During the two in -patient stays in the GCRC, blood and urine samples will be done to get heart and kidney function as well as a research echo. After enrollment, the study lasts for twelve weeks. There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw, 24 hour urine collection and resupply the study medication. There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw, 24 hour urine collection and resupply the study medication.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Group 2 (PSD) will consist of 20 subjects with an ejection fraction of less than 40% with no clinical signs or symptoms of congestive heart failure and a minimal distance on 6-minute walk of > 450 meters.
The subjects will all be on stable doses of an angiotensin converting enzyme (ACE) inhibitor for two weeks prior to the active study date.
Therapy with other vasodilators, beta-receptor antagonists, digoxin and antiarrhythmic medications will be allowed, however, all medications must be at stable doses two weeks prior to the study date.
- Exclusion criteria specification 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 CNS perfusion Total bilirubin of > 1.5 mg/dL or other liver enzymes >1.5 times the upper limit of normal Serum creatinine of > 3.0 mg/dL Serum sodium of < 125 mEq/dL or > 160 mEq/dL Serum potassium of < 3.5 mEq/dL or > 5.0 mEq/dL change to 5.3 Serum digoxin level of > 2.0 ng/ml Systolic pressure of < 85 mmHg Hemoglobin < 10 gm/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405639

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Horng H. Chen, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Horng Chen, Dr Horng H Chen, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00405639 History of Changes
Other Study ID Numbers:	05-004186
Study First Received:	November 29, 2006
Last Updated:	January 24, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012