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Описание
Краткое названиеA Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Полное названиеThe Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
СпонсорPfizer
Industry
ИсточникPfizer
Под контролемUnited States: Food and Drug Administration
Yes
Краткое описаниеIn an earlier study, eplerenone was shown to improve survival in patients who had heart
failure immediately following a heart attack. However, it is not known how patients with
established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of
sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus
standard heart failure medicines is being compared to placebo plus standard heart failure
medicines in terms of an additional ability to prolong life and prevent re-hospitalizations
for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the
protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of
eplerenone had met the pre-specified stopping rules in the protocol. As a result of the
discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended
that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the
consideration that it would be unethical not to offer this treatment to patients, the ESC
recommended that all the patients in the trial should be transferred to open-label
eplerenone. Eplerenone is not currently approved for the indication studied in this
patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is
considered to be the most appropriate way to ensure that all the subjects who participated
in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone.
This open-label-extension phase will last for 12 months.
СостояниеSuspended
Дата началаMarch 2006
ФазаPhase 3
Вид исследованияAllocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology
of at least 4 weeks duration; Currently, New York Heart Association (NYHA) functional
Class II and on optimal dose, or maximally tolerated dose of standard heart failure
medicines (advisable to include ACE-I/ARBs; beta-blockers) and diuretics if indicated
for fluid overload. Should have participated in the double-blind phase of the
EMPHASIS-HF trial

Exclusion Criteria:

- Severe chronic systolic heart failure symptomatic at rest despite optimal medical
therapy; estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
ПолBoth
Минимальный возраст55 Years
Максимальный возрастN/A
УсловиеHeart Failure
Применяемое лечение
DrugEplerenone
Контакты и расположение
Simferopol , 95026Pfizer Investigational Site
Dnipropetrovsk , 49060Pfizer Investigational Site
Dnipropetrovsk , 49005Pfizer Investigational Site
Dnipropetrovsk , 49023Pfizer Investigational Site
Donetsk , 83003Pfizer Investigational Site
Donetsk , 83114Pfizer Investigational Site
Kharkiv , 61002Pfizer Investigational Site
Kharkov , 61000Pfizer Investigational Site
Kiev , 03151Pfizer Investigational Site
Kyiv , 02125Pfizer Investigational Site
Kyiv , 04050Pfizer Investigational Site
Lviv , 79013Pfizer Investigational Site
Lviv , 79015Pfizer Investigational Site
Odessa , 65044Pfizer Investigational Site
Odessa , 65039Pfizer Investigational Site
Uzhgorod , 88018Pfizer Investigational Site
Zaporizhzhia , 69118Pfizer Investigational Site
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