The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design

Area of Science:

• Cardiology
• Clinical Trials
• Pharmacology

Background:

• Heart failure with preserved systolic function (HF-PSF) affects 40-50% of chronic heart failure patients.
• Limited clinical trials and evidence-based treatment guidelines exist for HF-PSF.
• This population remains understudied, necessitating further research.

Purpose of the Study:

• To evaluate the efficacy of irbesartan in treating patients with HF-PSF.
• To determine if irbesartan reduces mortality and cardiovascular hospitalizations.
• To provide crucial information on the characteristics and course of HF-PSF.

Main Methods:

• The Irbesartan in Heart Failure with Preserved Systolic Function (I-PRESERVE) trial enrolled 4100 subjects.
• Inclusion criteria: age ≥60 years, HF symptoms, ejection fraction ≥45%, and recent HF hospitalization or evidence of diastolic dysfunction.
• Primary endpoint: reduction in mortality and cardiovascular hospitalizations; secondary endpoints: mortality, morbidity, functional class, quality of life, and N-terminal pro-BNP.

Main Results:

• The I-PRESERVE trial is the largest study conducted in the HF-PSF population.
• Enrollment of 4100 subjects with detailed inclusion criteria for HF-PSF.
• The study is designed to provide significant data on treatment efficacy and patient characteristics.

Conclusions:

• I-PRESERVE is a landmark trial for the understudied HF-PSF population.
• The study will yield crucial data on the characteristics and progression of HF-PSF.
• Findings will inform the efficacy of irbesartan, an angiotensin receptor blocker, in this patient group.