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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

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

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

NCT ID

NCT00585611

First Posted

December 26, 2007

Last Updated

March 6, 2019

Sponsor

University of Wisconsin, Madison

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

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

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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