NCT00505336

Brief 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. 1.To investigate the impact of aldosterone antagonism or statin therapy on markers of collagen turnover in patients with diastolic heart failure.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

July 19, 2007

Last Update Submit

February 10, 2009

Conditions

Diastolic Heart Failure

Keywords

Diastolic heart failureMarkers of collagen turnoverStatinsAldosterone receptor blockers

Outcome Measures

Primary Outcomes (1)

  • To investigate the impact of aldosterone antagonism or statin therapy on markers of collagen turnover in patients with diastolic heart failure.

    12 months

Secondary Outcomes (3)

  • To assess the impact of aldosterone antagonism or statin therapy on markers of diastolic dysfunction by echocardiography

    12 months

  • To assess the impact of aldosterone antagonism or statin therapy on indices of clinical well being

    12 months

  • The assess the impact of aldosterone antagonism or statin therapy on diastolic indices by cardiac MRI

    12 months

Study Arms (3)

1

EXPERIMENTAL

Eplerenone

Drug: Eplerenone

3

ACTIVE COMPARATOR

no additional treatment

Other: No additional treatment

2

EXPERIMENTAL

Atorvastatin

Drug: Atorvastatin

Interventions

EplerenoneDRUG

oral Eplerenone titrated to 50mg for duration of 12 months

Also known as: Inspra
1
No additional treatmentOTHER

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

3
AtorvastatinDRUG

oral Atorvastatin 40mg

Also known as: Lipitor
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diastolic heart failure.
  • Diastolic heart failure is defined as symptoms of heart failure with an ejection fraction \>45%, BNP \>100pg/ml and Doppler evidence of diastolic dysfunction.

You may not qualify if:

  • Clinically unstable as defined by any change in diuretic dose in the month prior to enrolment.
  • Evidence of significant inflammatory disease or hepatic disease or metabolic bone disease which may alter parameters of collagen metabolism.
  • Patients already receiving statin, aldosterone or eplerenone therapy
  • Pregnant women and women of child bearing age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's University Hospital

Ballsbridge, Dublin, 4, Ireland

Location

Related Publications (1)

  • Mak GJ, Ledwidge MT, Watson CJ, Phelan DM, Dawkins IR, Murphy NF, Patle AK, Baugh JA, McDonald KM. Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone. J Am Coll Cardiol. 2009 Oct 27;54(18):1674-82. doi: 10.1016/j.jacc.2009.08.021.

    PMID: 19850207DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

EplerenoneAtorvastatin

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Ken McDonald, MD FRCP

    Heart Failure Unit, St Vincent's University Hospital

    STUDY DIRECTOR

  • George Mak, MB MRCPI

    St Vincent's University Hospital, Ireland

    PRINCIPAL INVESTIGATOR

  • Niamh Murphy, MD MRCPI

    St Vincent's University Hospital, Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 23, 2007

Study Start

April 1, 2006

Primary Completion

July 1, 2008

Study Completion

December 1, 2008

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

IE(1)