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

Primary Purpose

Diastolic Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
placebo
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring Heart Failure, Congestive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

2

Arm Description

Heart failure patients assigned to atorvastatin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Composite Cardiovascular Endpoint Incorporating Quality of Life (QOL) Assessment + Hospitalizations for Cardiovascular Disease and Mortality
Changes in Submaximal Exercise Capacity Measured by 6-minute Walk Test

Full Information

First Posted
December 26, 2007
Last Updated
March 6, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00585611
Brief Title
Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients
Official Title
Effects of Statin Therapy on Vascular Properties and Outcomes in Diastolic Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit into the study
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
Keywords
Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Heart failure patients assigned to atorvastatin
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin - 40 mg orally daily for 6 months
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change in Carotid-femoral Pulse Wave Velocity (CFPWV) in the Statin Treated vs. Control Group
Time Frame
6 months after initiation of intervention
Secondary Outcome Measure Information:
Title
Composite Cardiovascular Endpoint Incorporating Quality of Life (QOL) Assessment + Hospitalizations for Cardiovascular Disease and Mortality
Time Frame
6 months after initiation of intervention
Title
Changes in Submaximal Exercise Capacity Measured by 6-minute Walk Test
Time Frame
6 months after initiation of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: ECG or echocardiographic evidence of moderate/severe left ventricular hypertrophy, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy K Sweitzer, MD PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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