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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Atorvastatin; Atorvastatin Calcium

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.