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

NCT00585611 | Terminated Results DMC

• 1 other identifier: H-2005-0430
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diastolic Heart Failure

Keywords

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

• Change in Carotid-femoral Pulse Wave Velocity (CFPWV) in the Statin Treated vs. Control Group

  6 months after initiation of intervention

Secondary Outcomes (2)

• Composite Cardiovascular Endpoint Incorporating Quality of Life (QOL) Assessment + Hospitalizations for Cardiovascular Disease and Mortality

  6 months after initiation of intervention

• Changes in Submaximal Exercise Capacity Measured by 6-minute Walk Test

  6 months after initiation of intervention

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Heart failure patients assigned to atorvastatin

Drug: Atorvastatin

2

PLACEBO COMPARATOR

Drug: Atorvastatin; Other: placebo

Interventions

Atorvastatin DRUG

Atorvastatin - 40 mg orally daily for 6 months

2; Atorvastatin

placebo OTHER

placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ECG or echocardiographic evidence of moderate/severe left ventricular hypertrophy,
• chest x-ray evidence of pulmonary congestion

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Heart Failure

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

PI left UW-Madison, has no data for participant enrolled.

Results Point of Contact

• Title: Nancy Sweitzer
• Organization: UW-Madison at time of study

nancysweitzer@shc.arizona.edu

Study Officials

• Nancy K Sweitzer, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: December 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 26, 2019
• Results First Posted: March 26, 2019

Record last verified: 2019-03

Locations

US (1)