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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00095238




Registration number
NCT00095238
Ethics application status
Date submitted
1/11/2004
Date registered
2/11/2004
Date last updated
7/04/2015

Titles & IDs
Public title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Scientific title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Secondary ID [1] 0 0
CV131-148
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Irbesartan
Treatment: Drugs - Placebo

Active comparator: 1 -

Placebo comparator: 2 -


Treatment: Drugs: Irbesartan
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

Treatment: Drugs: Placebo
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Timepoint [1] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [1] 0 0
Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Timepoint [1] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [2] 0 0
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Timepoint [2] 0 0
Baseline, Month 6, Month 14
Secondary outcome [3] 0 0
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Timepoint [3] 0 0
Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Secondary outcome [4] 0 0
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Timepoint [4] 0 0
Baseline, Month 6, Month 14
Secondary outcome [5] 0 0
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Timepoint [5] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
Timepoint [6] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [7] 0 0
Percentage of Participants Experiencing All-cause Death at Given Time Points
Timepoint [7] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [8] 0 0
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
Timepoint [8] 0 0
Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Secondary outcome [9] 0 0
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Timepoint [9] 0 0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Secondary outcome [10] 0 0
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Timepoint [10] 0 0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Secondary outcome [11] 0 0
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
Timepoint [11] 0 0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Secondary outcome [12] 0 0
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
Timepoint [12] 0 0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Secondary outcome [13] 0 0
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
Timepoint [13] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [14] 0 0
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
Timepoint [14] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [15] 0 0
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
Timepoint [15] 0 0
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcome [16] 0 0
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
Timepoint [16] 0 0
Baseline, Month 6, Month 18, Month 30
Secondary outcome [17] 0 0
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
Timepoint [17] 0 0
Baseline, Month 42, Month 54, Month 66
Secondary outcome [18] 0 0
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
Timepoint [18] 0 0
Baseline, Final Visit

Eligibility
Key inclusion criteria
* Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
* 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
4128
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Garran
Recruitment hospital [4] 0 0
Local Institution - Kogarah
Recruitment hospital [5] 0 0
Local Institution - Randwick
Recruitment hospital [6] 0 0
Local Institution - Auchenflower
Recruitment hospital [7] 0 0
Local Institution - Brisbane
Recruitment hospital [8] 0 0
Local Institution - Woolloongabba
Recruitment hospital [9] 0 0
Local Institution - Launceston
Recruitment hospital [10] 0 0
Local Institution - Geelong
Recruitment hospital [11] 0 0
Local Institution - Prahran
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Garran
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- Kogarah
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment postcode(s) [6] 0 0
- Auchenflower
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- Brisbane
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment postcode(s) [9] 0 0
- Launceston
Recruitment postcode(s) [10] 0 0
- Geelong
Recruitment postcode(s) [11] 0 0
- Prahran
Recruitment outside Australia
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Londonderry

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00095238