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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00585806 |
This study will compare the ability of the heart to increase its contractile performance during stress in patients with a history of heart failure without systolic dysfunction and in controls.
Condition |
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Heart Failure |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF) |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Subjects with Heart Failure and ejection fraction greater than or equal to 45%
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2
Healthy Volunteers
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There will be two groups of 20 subjects recruited in a collaborative effort by UWHC and University of Pennsylvania. This project will require one visit approximately 3-5 hours in length. The subject will fill out a symptom questionnaire. A small gauge angiocath will be place to establish intravenous access. Single-lead ECG and blood pressure are monitored for the duration of the protocol. Tonometry (non-invasive measurement of the pulse) and echocardiographic images will be obtained at baseline. After baseline data are obtained, dobutamine will be infused at escalating doses of 2, 4, 8, and 16 µg/kg/min IV at ≤30-minute intervals. After 5 minutes of infusion at each dose, echocardiographic and tonometry data will be recorded. If 85% or more of predicted target heart rate is reached, the final study data collection and safety imaging will be performed and the dose not increased further.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Potential subjects will be identified from the heart failure population scheduled for visits to the heart failure clinic, use of the GIM Funneling Project and the University of Wisconsin Institute on Aging.
Inclusion Criteria:
Exclusion Criteria:
Contact: Todd Forsythe | 608-263-1544 | tmforsythe@medicine.wisc.edu |
Contact: Mauricio Velez, MD | 608-263-1544 | mxv@medicine.wisc.edu |
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Todd Forsythe 608-263-1544 tmforsythe@medicine.wisc.edu | |
Principal Investigator: Nancy K Sweitzer, Md, PhD |
Principal Investigator: | Nancy K Sweitzer, MD, PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( Nancy K. Sweitzer MD, PhD ) |
Study ID Numbers: | HSC# 2005-0408, UW grant:133 ET18 A53 4225 |
Study First Received: | December 26, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00585806 |
Health Authority: | United States: Food and Drug Administration |
Heart Failure with preserved ejection fraction |
Heart Failure Heart Diseases |
Cardiovascular Diseases |