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

This study has been completed.
Sponsor:
Collaborators:
University of Dublin, Trinity College
University College Dublin
University College Cork
Information provided by:
St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT00795912
First received: November 19, 2008
Last updated: November 20, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention Phase
Heart Failure
 Drug: Atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St Vincent's University Hospital, Ireland:

Primary Outcome Measures:
  • hsCRP, TNF-alpha, IL-6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • B-Type Natriuretic Peptide Markers of collagen turnover [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2003
Study Completion Date: January 2008
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: November 19, 2008
Last Updated: November 20, 2008
Health Authority: Ireland: Ministry of Health
Ireland: Irish Medicines Board

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
Inflammation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Natriuretic Peptide, Brain
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 17, 2013