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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00620308 |
This human physiologic study will evaluate the effects of a new drug called CD-NP in individuals with stable chronic heart failure, with a focus on evaluating responses of the kidneys and the hormonal system.
Condition | Intervention | Phase |
---|---|---|
Stable Chronic Heart Failure |
Drug: CD-NP Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A Human Physiologic Study to Evaluate the Renal and Neurohumoral Effects of a Novel Chimeric Natriuretic Peptide, CD-NP, in Subjects With Stable Chronic Heart Failure |
Estimated Enrollment: | 27 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
CD-NP is a novel chimeric natriuretic peptide which was created by combining the 22 amino acids of human C-type natriuretic peptide (CNP) and the 15-amino-acid C-terminus of Dendroaspis natriuretic peptide (DNP). The rationale for selecting CNP, a natriuretic peptide of endothelial cell origin, is that it exhibits predominantly venodilating effects, which may minimize systemic hypotension. Moreover, its anti-proliferative action is also a highly desirable property for novel cardiovascular drugs. However, a limitation of CNP is that it does not exert significant renal actions, whereas, DNP is potently natriuretic and diuretic. Thus, CD-NP was synthesized with the goal of combining the above complementary profiles of CNP and DNP into a single chimeric peptide.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ruth E Kempf, RN | 507-266-1994 | kempf.ruth@mayo.edu |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55901 |
Study Director: | John C. Burnett, Jr., MD | Mayo Foundation |
Responsible Party: | Mayo Foundation ( John C. Burnett, Jr., MD ) |
Study ID Numbers: | 07-005523 |
Study First Received: | February 10, 2008 |
Last Updated: | February 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00620308 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |