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A Study Of The Usage Of Statins In A Community Heart Failure Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00795912
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : November 21, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Inflammation and fibrosis may be important contributors to worsening heart failure. As well as lowering cholesterol, statins are also known to reduce inflammatory markers such as C-reactive protein which are elevated in severe heart failure. Therefore, this project will evaluate the benefit, if any, of statins on markers of heart structure and function, on inflammatory markers and markers of fibrosis in patients with normal cholesterol.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Atorvastatin Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Of The Usage Of Statins In A Community Heart Failure Population: The Impact of HMG Co-Enzyme A Reductase Inhibitors on Heart Structural Parameters, Brain Naturetic Peptide, Markers of Inflammation and Fibrosis
Study Start Date : May 2003
Primary Completion Date : November 2005
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Atorvastatin titrated from 10-40 mg/day over 3 months and maintained at 40mg/day for a further 3 months
Drug: Atorvastatin
atorvastatin titrated from 10-40 mg/day over 3 months and maintained at 40mg/day for a further 3 months
Other Name: Lipitor
No Intervention: 2
Usual medical care of heart failure


Outcome Measures

Primary Outcome Measures :
  1. hsCRP, TNF-alpha, IL-6 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. B-Type Natriuretic Peptide Markers of collagen turnover [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild to moderate HF (NYHA class II-III) of any aetiology and documented left ventricular systolic dysfunction (LVEF < 45%) by echocardiography within 3 months of randomization. These patients were clinically stable, on optimal HF medical therapy which had remained unaltered for at least four weeks prior to recruitment. All had normal fasting total cholesterol.

Exclusion Criteria:

  • Those receiving lipid lowering agents; those with absolute or relative contraindications to statins; those with known chronic inflammatory conditions; patients with medical conditions requiring anti-inflammatory or immuno-suppressive therapies.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795912


Locations
Ireland
Heart Failure Unit, St Vincents University Hospital
Dublin, Co Dublin, Ireland, 4
Sponsors and Collaborators
St Vincent's University Hospital, Ireland
University of Dublin, Trinity College
University College Dublin
University College Cork
Investigators
Principal Investigator: Mark T Ledwidge, PhD St Vincent's University Hospital
Principal Investigator: Kenneth M McDonald, MD St Vincent's University Hospital
Principal Investigator: Esam Abulhul, MB St Vincents University Hospital
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Ken McDonald, St Vincent's University Hospital and University College, Dublin
ClinicalTrials.gov Identifier: NCT00795912     History of Changes
Other Study ID Numbers: SVUH -HFU-015
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008

Keywords provided by St Vincent's University Hospital, Ireland:
Systolic heart failure
HMG CoA reductase inhibitors
B-type natriuretic peptide
Inflammation
Myocardial collagen turnover

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors