Status:
COMPLETED
Nesiritide and Vo2 Max in Heart Failure Patients
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Scios, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the Department of Medicine at the University of Rochester School of Medicine and Dentistry investigates the pote...
Detailed Description
See above comments.
Eligibility Criteria
Inclusion
- Aged 18-65 with NYHA Class II or III heart failure
- Referred to Strong Memorial Hospital for consideration of heart transplant
- Male or female and infertile or using effective contraception with negative pregnancy test
- Capable of IV access
- Able to perform a maximal bicycle test and tolerate mouthpiece and nose clip
- Fully understands and has signed Informed Consent Form before study begins
- Endogenous BNP level of at least 100 pg/mL
- Current smokers smoking \< 3 cigarettes / day. Smoking is not permitted within the hospital, ergo subjects would not be permitted to smoke during study participation.
Exclusion
- NYHA Class i or IV heart failure
- Creatinine clearance \< 30 ml/min, as determined within 2 weeks of the start of the study
- EF \> 40%
- Evidence of primary lung disease
- Hypersensitivity to nesiritide or any of its' components
- Current smokers as defined by \> 3 cigarettes / day
- Stroke within 3 months, myocardial infarction within 2 months, or any evidence of active myocardial ischemia
- Unwillingness ir inability to remain in the hospital overnight
- Clinical condition or laboratory abnormality which may increase risks associated with participation or interfere with result interpretation
- Any condition which would preclude heart transplantation.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00240084
Start Date
July 1 2003
End Date
November 1 2005
Last Update
June 19 2013
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642