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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00585611 |
The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. This study is designed to investigate the effects of therapy with atorvastatin in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial structure and function, with particular emphasis on arterial stiffness and endothelial dysfunction.
Condition | Intervention |
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Diastolic Heart Failure |
Drug: Atorvastatin Other: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients |
Estimated Enrollment: | 40 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Atorvastatin
Atorvastatin - 40 mg orally daily for 6 months
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2: Placebo Comparator |
Other: placebo
placebo
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Forty subjects will be given either drug (atorvastatin 40 mg) or placebo in a randomized fashion once daily for six months. Using echocardiography, tonometry, and flow mediated dilation of conduit arteries and arterioles, baseline cardiovascular anatomy and physiology will be defined. Subjects that enroll in the study will be required to come in for 5 study visits. The initial visit is a screening visit; subject consent is obtained and an echocardiogram is performed as well as blood tests. At the randomization visit (4-14 days following screening), the subject will be provided with drug or placebo in a blinded fashion.Also at this visit, subjects will be asked to do a 6 minute walk, QOL questionnaire, and vascular function testing. There will be follow-up study visits at 1 and 3 months following randomization. At each follow-up visit a medical history, pill count and brief physical examination will be performed, a repeat QOL questionnaire administered, and blood tests to assess safety of the statin therapy. At 6 months, the final study visit will occur. At this visit a full history and detailed physical examination will be performed. Repeat echocardiogram, 6 minute walk test, QOL questionnaire, and vascular function examinations will be performed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
current NYHA Class III-IV symptoms and one of the following:
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 | |
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# 2005-430 |
Study First Received: | December 26, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00585611 |
Health Authority: | United States: Food and Drug Administration |
Heart Failure, Congestive |
Heart Failure, Diastolic Heart Failure Heart Diseases Atorvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |