Clinical trial NCT00095238: Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Official title: Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congestive Heart Failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2004-11-02
Enrollment: 4128
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
Secondary outcomes:
measure: Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
timeFrame: Baseline, Month 6, Month 14
measure: Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
timeFrame: 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.
measure: Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
timeFrame: Baseline, Month 6, Month 14
measure: Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Percentage of Participants Experiencing All-cause Death at Given Time Points
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
timeFrame: 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.
measure: Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
timeFrame: 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.
measure: Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
timeFrame: 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.
measure: Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
timeFrame: 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.
measure: Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
timeFrame: 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.
measure: Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
timeFrame: Baseline, Month 6, Month 18, Month 30
measure: Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
timeFrame: Baseline, Month 42, Month 54, Month 66
measure: Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
timeFrame: Baseline, Final Visit
Other outcomes:
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city: Rosario
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city: Concord
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city: Geelong
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city: AYE
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city: Borgerhout
country: Belgium
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city: Genk-waterschei
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city: Gent
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city: Belo Horizonte
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city: Campinas
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city: Sao Paulo, Sp
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city: Zaandam
country: Netherlands
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city: Baerum Postterminal
country: Norway
facility: Local Institution
city: Stavanger
country: Norway
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city: Tonsberg
country: Norway
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Katowice
country: Poland
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city: Piotrkow Tryb.
country: Poland
facility: Local Institution
city: Stalowa Wola
country: Poland
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city: Warszawa
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
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city: Lisbon
country: Portugal
facility: Local Institution
city: Matosinhos
country: Portugal
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Morningside
country: South Africa
facility: Local Institution
state: Gauteng
city: Parktown West
country: South Africa
facility: Local Institution
state: Gauteng
city: Berea
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Congella
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
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facility: Local Institution
city: Cordoba
country: Spain
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city: Madrid
country: Spain
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city: Malaga
country: Spain
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city: Murcia
country: Spain
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city: Palma de Mallorca
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
city: Falun
country: Sweden
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Linkoping
country: Sweden
facility: Local Institution
city: Malmo
country: Sweden
facility: Local Institution
city: Skelleftea
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Sundsvall
country: Sweden
facility: Local Institution
city: Bellinzona
country: Switzerland
facility: Local Institution
city: Liestal
country: Switzerland
facility: Local Institution
city: Zuerich
country: Switzerland
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Dumbartonshire
city: Romford
country: United Kingdom
facility: Local Institution
state: Essex
city: Hull
country: United Kingdom
facility: Local Institution
state: Yorkshire
city: York
country: United Kingdom
facility: Local Institution
state: Yorkshire
city: Dundee
country: United Kingdom
facility: Local Institution
city: Londonderry
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
citation: Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE; I-Preserve Investigators. Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation. 2010 Mar 30;121(12):1393-405. doi: 10.1161/CIRCULATIONAHA.109.909614. Epub 2010 Mar 15.
citation: McMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008 Feb;10(2):149-56. doi: 10.1016/j.ejheart.2007.12.010.
citation: Carson P, Massie BM, McKelvie R, McMurray J, Komajda M, Zile M, Ptaszynska A, Frangin G; I-PRESERVE Investigators. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail. 2005 Oct;11(8):576-85. doi: 10.1016/j.cardfail.2005.06.432.
citation: McKelvie RS, Komajda M, McMurray J, Zile M, Ptaszynska A, Donovan M, Carson P, Massie BM; I-Preserve Investigators. Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial. J Card Fail. 2010 Feb;16(2):128-34. doi: 10.1016/j.cardfail.2009.09.007. Epub 2009 Nov 4.
citation: Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
citation: Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.
citation: Kristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.
citation: Kristensen SL, Mogensen UM, Jhund PS, Petrie MC, Preiss D, Win S, Kober L, McKelvie RS, Zile MR, Anand IS, Komajda M, Gottdiener JS, Carson PE, McMurray JJ. Clinical and Echocardiographic Characteristics and Cardiovascular Outcomes According to Diabetes Status in Patients With Heart Failure and Preserved Ejection Fraction: A Report From the I-Preserve Trial (Irbesartan in Heart Failure With Preserved Ejection Fraction). Circulation. 2017 Feb 21;135(8):724-735. doi: 10.1161/CIRCULATIONAHA.116.024593. Epub 2017 Jan 4.
citation: Gandhi PU, Chow SL, Rector TS, Krum H, Gaggin HK, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Carson PE, Januzzi JL Jr, Anand IS. Prognostic Value of Insulin-Like Growth Factor-Binding Protein 7 in Patients with Heart Failure and Preserved Ejection Fraction. J Card Fail. 2017 Jan;23(1):20-28. doi: 10.1016/j.cardfail.2016.06.006. Epub 2016 Jun 16.
citation: Badar AA, Perez-Moreno AC, Hawkins NM, Jhund PS, Brunton AP, Anand IS, McKelvie RS, Komajda M, Zile MR, Carson PE, Gardner RS, Petrie MC, McMurray JJ. Clinical Characteristics and Outcomes of Patients With Coronary Artery Disease and Angina: Analysis of the Irbesartan in Patients With Heart Failure and Preserved Systolic Function Trial. Circ Heart Fail. 2015 Jul;8(4):717-24. doi: 10.1161/CIRCHEARTFAILURE.114.002024. Epub 2015 Jun 11.
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