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Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
This study has been completed.
First Received: November 1, 2004   Last Updated: October 10, 2008   History of Changes
Sponsor: Bristol-Myers Squibb
Collaborator: Sanofi-Aventis
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00095238
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
 Drug: Irbesartan
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
Drug Information available for: Irbesartan
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4129
Study Start Date: June 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Irbesartan
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
2: Placebo Comparator Drug: Placebo
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095238

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Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi-Aventis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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.

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CV131-148
Study First Received: November 1, 2004
Last Updated: October 10, 2008
ClinicalTrials.gov Identifier: NCT00095238     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
 Irbesartan
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009



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