The Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart Failure

NCT00505336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2009-02-11

No results posted yet for this study

Summary

To investigate whether the medicines eplerenone or atorvastatin have a favourable effect on diastolic heart failure.

Eplerenone is a drug that has been shown to be beneficial in Chronic Heart Failure due to pump failure. It can increase life expectancy and improve symptoms in these patients. It is not known whether or not eplerenone might be beneficial in heart failure with normal pump function (diastolic heart failure).

Atorvastatin is one of a group of cholesterol lowering medicines called statins, which have been shown to reduce cardiovascular disease in patients irrespective of whether cholesterol levels are high or normal. It is not known whether atorvastatin also reduces fibrosis of the heart which is one of the causes of diastolic heart failure.

Study hypothesis

1. To investigate the impact of aldosterone antagonism or statin therapy on markers of collagen turnover in patients with diastolic heart failure.
2. To assess the impact of aldosterone antagonism or statin therapy on markers of diastolic dysfunction and indices of clinical well being in patients with diastolic heart failure.

Conditions

  • Diastolic Heart Failure

Interventions

DRUG

Eplerenone

oral Eplerenone titrated to 50mg for duration of 12 months

OTHER

No additional treatment

normal disease modifying therapy for heart failure i.e. ACE-I, beta blockers

DRUG

Atorvastatin

oral Atorvastatin 40mg

Sponsors & Collaborators

  • St Vincent's University Hospital, Ireland

    lead OTHER

Principal Investigators

  • Ken McDonald, MD FRCP · Heart Failure Unit, St Vincent's University Hospital

  • George Mak, MB MRCPI · St Vincent's University Hospital

  • Niamh Murphy, MD MRCPI · St Vincent's University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-07-31
Completion
2008-12-31

Countries

  • Ireland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505336 on ClinicalTrials.gov