Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients

This study has been terminated.
(Unable to recruit into the study)
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585611
First received: December 26, 2007
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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
Diastolic Heart Failure
Drug: Atorvastatin
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in carotid-femoral pulse wave velocity (CFPWV) in the statin treated vs. control group [ Time Frame: 6 months after initiation of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite cardiovascular endpoint incorporating quality of life (QOL) assessment + hospitalizations for cardiovascular disease and mortality [ Time Frame: 6 months after initiation of intervention ] [ Designated as safety issue: No ]
  • Changes in submaximal exercise capacity measured by 6-minute walk test [ Time Frame: 6 months after initiation of intervention ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: December 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Heart failure patients assigned to atorvastatin
Drug: Atorvastatin
Atorvastatin - 40 mg orally daily for 6 months
Placebo Comparator: 2 Drug: Atorvastatin
Atorvastatin - 40 mg orally daily for 6 months
Other: placebo
placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent,
  • Age > 18,
  • Ejection fraction ≥ 50%,
  • hospitalization for heart failure in the last 6 months and
  • current NYHA Class II-IV symptoms, OR
  • current NYHA Class III-IV symptoms and one of the following:

    1. ECG or echocardiographic evidence of moderate/severe left ventricular hypertrophy,
    2. chest x-ray evidence of pulmonary congestion

Exclusion Criteria:

  • Probable alternative cause of symptoms (pulmonary disease, severe anemia, etc.)
  • Prior documented LVEF < 40% or qualitative moderate or greater LV systolic dysfunction.
  • Current indication for statin therapy
  • Intolerance to statin therapy.
  • Documented ischemic heart disease requiring lipid-lowering therapy (i.e. CAD, myocardial infarction, stroke)
  • Evidence of significant myocardial ischemia on stress testing at screening visit.
  • Evidence of hepatic abnormality (defined as liver enzymes > 2 times the upper limit of normal values).
  • Uncontrolled hypertension (BP > 150/100)
  • Significant valvular disease.
  • Atrial fibrillation
  • Known familial hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy.
  • Restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease (i.e. amyloidosis, sarcoidosis, hemochromatosis).
  • Cor pulmonale or other cause of right heart failure not related to LV dysfunction.
  • Clinically significant pulmonary disease.
  • Pericardial constriction or hemodynamically significant pleural effusion.
  • Uncontrolled arrhythmia.
  • Any systemic condition other than heart failure that may limit survival to less than 2 years.
  • Advance renal disease (serum creatinine > 3.0 mg/dl or on dialysis)
  • Known intolerance or allergy to HMG CoA reductase inhibitors
  • Uncontrolled hyper- or hypothyroidism.
  • Any subject characteristic that may interfere with study compliance, such as baseline dementia, substance abuse, history of non-compliance with medications or appointments.
  • Prisoners or other vulnerable populations.
  • Any woman of child-bearing age with a documented positive pregnancy test.
  • Subject is receiving therapy with other investigational therapy or is participating in any other clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585611

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Nancy K Sweitzer, MD PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Nancy K. Sweitzer MD PhD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00585611     History of Changes
Other Study ID Numbers: HSC# 2005-430
Study First Received: December 26, 2007
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Heart Failure, Congestive

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014