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

December 26, 2007
May 13, 2011
December 2005
June 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00585611 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients
Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diastolic Heart Failure
  • Drug: Atorvastatin
    Atorvastatin - 40 mg orally daily for 6 months
  • Other: placebo
    placebo
  • Experimental: Atorvastatin
    Heart failure patients assigned to atorvastatin
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: 2
    Interventions:
    • Drug: Atorvastatin
    • Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585611
HSC# 2005-430
Yes
Nancy K. Sweitzer MD PhD, University of Wisconsin
University of Wisconsin, Madison
Not Provided
Principal Investigator: Nancy K Sweitzer, MD PhD University of Wisconsin, Madison
University of Wisconsin, Madison
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP