Trial · NCT00095238
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
NCT00095238, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2010-06-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve). Trials, record NCT00095238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095238
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
- NCT number
- NCT00095238
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,128 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Congestive Heart Failure
- Interventions
- Irbesartan, Placebo
- First posted
- 2004-11-02
- Last updated
- 2015-04-07
- Results first posted
- 2010-06-08
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Year 1, Year 2, Year 3, Year 4, Year 5 | Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included. |
| Secondary | Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points | Year 1, Year 2, Year 3, Year 4, Year 5 | Treatment comparisons for time to heart failure mortality or heart failure hospitalization |
| Secondary | Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14 | Baseline, Month 6, Month 14 | Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure. |
| Secondary | Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit | 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. | Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure. |
| Secondary | Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14 | Baseline, Month 6, Month 14 | Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values. |
| Secondary | Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints | Year 1, Year 2, Year 3, Year 4, Year 5 | Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke. |
| Secondary | Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints | Year 1, Year 2, Year 3, Year 4, Year 5 | Treatment comparisons for time to cardiovascular death |
| Secondary | Percentage of Participants Experiencing All-cause Death at Given Time Points | Year 1, Year 2, Year 3, Year 4, Year 5 | Treatment comparisons for time to all-cause death |
| Secondary | Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit | 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. | NYHA functional classification=4-tiered system relating symptoms to everyday activities \& quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form \[CRF\] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event. |
| Secondary | Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline | 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. | This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Year 1, Year 2, Year 3, Year 4, Year 5 | Randomized Participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points | Year 1, Year 2, Year 3, Year 4, Year 5 | Randomized Participants | percentage of participants | NUMBER |
| SECONDARY | Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14 | Baseline, Month 6, Month 14 | Participants with baseline score and score at timepoint. | units on a scale | MEAN |
| SECONDARY | Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit | 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. | Participants with baseline score and score at timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14 | Baseline, Month 6, Month 14 | number of participants with measurement at baseline and at timepoint | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints | Year 1, Year 2, Year 3, Year 4, Year 5 | Randomized Participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints | Year 1, Year 2, Year 3, Year 4, Year 5 | Randomized Subjects | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing All-cause Death at Given Time Points | Year 1, Year 2, Year 3, Year 4, Year 5 | Randomized subjects | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit | 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. | Randomized participants with measurement at baseline and Month 6, Month 10, Month 14, and Final Visit | participants | NUMBER |
| SECONDARY | Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline | 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. | participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group480
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Irbesartan | Percentage at 1 Year | 12.3 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Placebo | Percentage at 1 Year | 12.1 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Irbesartan | Percentage at 2 Years | 20.7 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Placebo | Percentage at 2 Years | 21.3 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Irbesartan | Percentage at 3 Years | 26.4 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Placebo | Percentage at 3 Years | 28.4 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Irbesartan | Percentage at 4 Years | 32.9 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Placebo | Percentage at 4 Years | 34.2 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Irbesartan | Percentage at 5 Years | 39.2 | percentage of participants | |
| Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints | Placebo | Percentage at 5 Years | 39.5 | percentage of participants |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Irbesartan | 2,067 | |
| Overall Study | STARTED | Placebo | 2,061 | |
| Overall Study | Safety (Treated) Population | Irbesartan | 2,064 | |
| Overall Study | Safety (Treated) Population | Placebo | 2,062 | |
| Overall Study | COMPLETED | Irbesartan | 1,210 | |
| Overall Study | COMPLETED | Placebo | 1,209 | |
| Overall Study | NOT COMPLETED | Irbesartan | 857 | |
| Overall Study | NOT COMPLETED | Placebo | 852 |
Source ClinicalTrials.gov
Adverse events1,962
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | CARDIAC FAILURE | Cardiac disorders | IRBESARTAN | 133 | 2,064 | |
| other | CARDIAC FAILURE | Cardiac disorders | PLACEBO | 134 | 2,062 | |
| other | ATRIAL FIBRILLATION | Cardiac disorders | IRBESARTAN | 108 | 2,064 | |
| other | ATRIAL FIBRILLATION | Cardiac disorders | PLACEBO | 110 | 2,062 | |
| other | HYPOTENSION | Vascular disorders | IRBESARTAN | 203 | 2,064 | |
| other | HYPOTENSION | Vascular disorders | PLACEBO | 93 | 2,062 | |
| other | HYPERTENSION | Vascular disorders | IRBESARTAN | 202 | 2,064 | |
| other | HYPERTENSION | Vascular disorders | PLACEBO | 252 | 2,062 | |
| other | HEADACHE | Nervous system disorders | IRBESARTAN | 126 | 2,064 | |
| other | HEADACHE | Nervous system disorders | PLACEBO | 138 | 2,062 |
1 to 10 of 1,962Source ClinicalTrials.gov
See all 1,962 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IRBESARTAN | ||
| Total, all-cause mortality | PLACEBO | ||
| Total, other adverse events | IRBESARTAN | 1,255 | 2,064 |
| Total, other adverse events | PLACEBO | 1,191 | 2,062 |
| Total, serious adverse events | IRBESARTAN | 1,146 | 2,064 |
| Total, serious adverse events | PLACEBO | 1,155 | 2,062 |
Source ClinicalTrials.gov
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IRBESARTAN vs PLACEBO: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00095238
GET https://conductscience.org/api/trials/v1/NCT00095238/results?page=2