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I-PRESERVE TRIAL |
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| Problem | Heart failure (EF > 45; NYHA II+) |
| Format | - |
| Treatment | Irbesartan |
| Control | Placebo |
| Population | 4128 patients |
| Inclusion criteria | At least 60 years of age Heart failure symptoms Left ventricular ejection fraction of at least 45% Required patients to have been hospitalized for heart failure during the previous 6 months Current New York Heart Association (NYHA) class II, III, or IV symptoms with corroborative evidence If they had not been hospitalized, they were required to have ongoing class III or IV symptoms with corroborative evidence, e.g. -Pulmonary congestion on radiography -Left ventricular hypertrophy or left atrial enlargement on echocardiography -Left ventricular hypertrophy or left bundle-branch block on electrocardiography Treatment with an angiotensin-converting–enzyme (ACE) inhibitor was permitted only when such therapy was considered essential for an indication other than uncomplicated hypertension. |
| Exclusion criteria | Previous intolerance to an angiotensin-receptor blocker Alternative probable cause of the patient's symptoms (e.g., significant pulmonary disease) Any previous left ventricular ejection fraction below 40% History of acute coronary syndrome, coronary revascularization, or stroke within the previous 3 months Substantial valvular abnormalities Hypertrophic or restrictive cardiomyopathy Pericardial disease; cor pulmonale or other cause of isolated right heart failure Systolic blood pressure of less than 100 mm Hg or more than 160 mm Hg Diastolic blood pressure of more than 95 mm Hg despite antihypertensive therapy Other systemic disease limiting life expectancy to less than 3 years Substantial laboratory abnormalities (such as a hemoglobin level of less than 11 g per deciliter, creatinine level of more than 2.5 mg per deciliter [221 Î_mol per liter], or liver-function abnormalities) Characteristics that might interfere with compliance with the study protocol. |
| Follow-up | Mean 49.5 months |
| Primary endpoint | Composite of death from any cause or hospitalization for a protocol-specified cardiovascular cause |
| Secondary endpoint(s) | Components of the primary outcome (death from any cause and hospitalization for cardiovascular causes) Composite heart failure outcome (death due to worsening heart failure or sudden death or hospitalization due to worsening heart failure) Change in the total score on the Minnesota Living with Heart Failure scale at 6 months Change in the plasma level of NT-proBNP at 6 months Composite vascular-event outcome (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) Death from cardiovascular causes |
| Details | . |
| Brief summary: | Irbesartan no benefit in NYHA-II/diastolic dysfunction |
| PAPER: Irbesartan in patients with heart failure and preserved ejection fraction. | |
|---|---|
| Date | 4 Dec 2008 |
| Journal | N Engl J Med. 2008 Dec 4;359(23):2456-67. |
| Information | Irbesartan in NYHA II & 'diastolic HF' -No difference in death or CV hospitalisation -No benefits in any subgroup |