Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve) - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 2004

Last Updated Date

October 10, 2008

Start Date ^ICMJE

June 2002

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time from randomization to the first occurence of the composite outcome of death (all cause) or cardiovascular hospitalization [ Time Frame: Time from randomization to the first occurence ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Time from randomization to the first occurence of the composite outcome of death (all cause) or cardiovascular hospitalization

Change History

Complete list of historical versions of study NCT00095238 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cardiovascular death analyzed [ Time Frame: as time to event ] [ Designated as safety issue: No ]
All cause mortality analyzed [ Time Frame: as time to event ] [ Designated as safety issue: No ]
Combined vascular endpoint: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke analyzed [ Time Frame: as time to first event ] [ Designated as safety issue: No ]
Combined heart [ Time Frame: as time to event ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

1) Cardiovascular death analyzed as time to event
2) All cause mortality analyzed as time to event
3) Combined vascular endpoint: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke analyzed as time to first event
4) Combined heart

Descriptive Information

Brief Title ^ICMJE

Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

Official Title ^ICMJE

Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

Brief Summary

The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: Irbesartan
Drug: Placebo

Study Arms / Comparison Groups

Publications *

Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. Epub 2008 Nov 11.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

4129

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female of Age >= 60 years with heart failure with preserved systolic function of the heart.
Left ventricular ejection fraction (LVEF) > = 45%
Willing to provide written informed consent AND Hospitalization for heart failure within the past 6 months OR Various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.

Exclusion Criteria:

Acute myocardial infarction within 3 months;
Heart revascularization procedure within 3 months;
Hospitalization for angina within 3 months;
Other heart surgery
Life-threatening or uncontrolled arrhythmia
Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;
Stroke or surgery of the arteries in the brain within 3 months;
Serious lung disease which requires use of home oxygen.
Significantly low blood pressure
Significantly high blood pressure
Other known diseases that may limit life expectancy to <3 years;
Known or suspected bilateral kidney artery narrowing;
Geographic or social factors making study participation and follow-up impractical.

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00095238

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CV131-148

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Sanofi-Aventis

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP