IRB Number:

69-00

Trial Status:

Open for Enrollment

Why is this study being done?

The purpose of this research study is to evaluate the effects of cardiac hormone replacement with SQ (under the skin) injection of BNP (a hormone produced by the heart) on the pumping ability of the heart, kidney function and levels of different hormones in the blood.

Enrollment Goal=45 Enrollment to Date=9

Who is Eligible to Participate in the Study?

• Age: 18 years of age and older
• 
  Class II or III heart failure

Inclusion Criteria:


• Age > 18 years.
• 
  Resting LVEF of 35% or less (determined within 24hrs of recruitment by echocardiography, MUGA or left ventriculogram).
• 
  NYHA Class II or 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.


Exclusion Criteria

• 
  
  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 VT or V-Fib within 14 days of screening.
• 
  Second or third degree heart block without a permanent pacemaker.
• 
  CVA within 3 months of screening, or the evidence of significantly compromised CNS perfusion.
• 
  Total bilirubin of >1.5mg/dL or an AST or ALT 1.5 times the upper limit of normal.
• 
  Serum creatinine of >3.0mg/dL.
• 
  Serum sodium of <125mEq/dL or >160mEq/dL.
• 
  Serum potassium of <3.5mEq/dL or >5.0mEq/dL.
• 
  Serum digoxin level of >2.0ng/ml.
• 
  Systolic pressure of <85mmHg.
• 
  LVEF>35% within 24hrs of screening.
• 
  Unable to self-administer subcutaneous injection twice daily.
• 
  Diagnosed with AIDS or known positive HIV titer.
• 
  Other acute or chronic medical conditions or laboratory abnormality, which may increase the risks, associated with the study participation or may interfere with interpretation of the data.
• 
  Received an investigational drug within one month prior to dosing.
• 
  Unable to undergo Cardiac MRI ( i.e. Atrial fibrillation, PPM, ICD)
• 
  In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.
• 
  Hemoglobin < 12g/dl.

Minimum Age:

18

Additional Requirements / Information

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 eight weeks. The study requires three office visits in the Charlton Building and two inpatient stays, one for 48 hours and one for 24 hours, in the General Clinical Research Center (GCRC) at St. Marys Hospital. Blood sample will be drawn at each visit. Urine samples will be collected for four of the visits. During the two stays in the GCRC a 6-minute walk, an Echo (sound wave test of the heart), a cardiac MRI (heart scan), a kidney function test, and a quality of life questionnaire will be done each time. After enrollment the study lasts for eight weeks.

Who can I Contact for Additional Information on this Trial?

Dr. Horng H. Chen
Study Coordinator:Cathy Dvorak, RN (507) 284-9511 or pager 127-08898

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 08/27/2003