Phase 3
N=4,128
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00095238 ↗Enrolled (actual)
4,128
Serious AEs
55.8%
Results posted
Jun 2010
Primary outcome: Primary: Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints — 12.3; 12.1; 20.7; 21.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Irbesartan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints |
12.3; 12.1; 20.7; 21.3; 26.4; 28.4 | — |
| SECONDARY Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points |
7.9; 8.2; 12.9; 13.7; 15.7; 17.2 | — |
| SECONDARY Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14 |
42.7; 43.0; 42.7; 42.8; 32.9; 33.2 | — |
| SECONDARY Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit |
42.5; 38.9; 42.6; 38.3 | — |
| SECONDARY Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14 |
0.98; 0.93; 1.00; 1.01 | — |
| SECONDARY Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints |
5.2; 4.2; 8.7; 9.3; 12.9; 13.6 | — |
| SECONDARY Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints |
3.3; 3.0; 6.2; 6.5; 9.6; 10.0 | — |
| SECONDARY Percentage of Participants Experiencing All-cause Death at Given Time Points |
4.1; 3.8; 8.1; 8.6; 12.8; 13.8 | — |
| SECONDARY Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit |
55; 881; 936; 47; 834; 881 | — |
| SECONDARY Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline |
230; 198; 562; 575; 533; 529 | — |
| SECONDARY Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline |
235; 230; 552; 563; 529; 519 | — |
| SECONDARY Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline |
193; 200; 523; 519; 504; 471 | — |
| SECONDARY Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline |
255; 276; 549; 536; 512; 501 | — |
| SECONDARY Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints |
11.6; 11.4; 19.2; 20.0; 24.2; 25.8 | — |
| SECONDARY Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints |
9.7; 9.8; 16.3; 17.1; 20.5; 21.7 | — |
| SECONDARY Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints |
0.7; 1.2; 2.1; 2.8; 3.1; 3.9 | — |
| SECONDARY Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30 |
73.02; 73.13; 73.58; 73.49; 73.34; 74.37 | — |
| SECONDARY Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66 |
74.37; 74.95; 75.29; 75.17; 63.47; 71.84 | — |
| SECONDARY Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG) |
366; 344; 1089; 1102; 35; 29 | — |
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.
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT00095238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.