Clinical trial NCT01115855: Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
Official title: The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Double-blind
eplerenone
Japanese
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 221
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.

Detailed description: The aim of this study was to show consistency with the EMPHASIS-HF trial (NCT00232180), which was defined as a HR of the primary endpoint of below 1.

Eligibility criteria: Inclusion Criteria:

* Japanese chronic systolic heart failure patients with LVEF =\<30% by echocardiography and NYHA II or more
* Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic)

Exclusion Criteria:

* Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous coronary intervention within 30 days prior to randomization.
* Patients with serum potassium \>5.0 mmol/L or eGFR \<30 ml/min/1.73 m2.

Primary outcomes:
measure: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Secondary outcomes:
measure: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With With First Occurrence of All-Cause Mortality
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With With First Occurrence of Cardiovascular Mortality
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of All-cause Hospitalization
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of New Onset Diabetes Mellitus
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Number of Participants With First Occurrence of Hospitalization for Hyperkalemia
timeFrame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
measure: Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit
timeFrame: Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48)
measure: Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit
timeFrame: Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)
measure: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit
timeFrame: Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)
measure: Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit
timeFrame: Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)
measure: Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit
timeFrame: Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)
measure: Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit
timeFrame: Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Chubu Rosai Hospital
state: Aichi
city: Seto
country: Japan
facility: Tosei General Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: National Hospital Organization Chiba Medical Center
state: Chiba-ken
city: Asahi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Inzai
country: Japan
facility: Nippon Medical School Chiba Hokusou Hospital
state: Chiba
city: Matuyama-shi
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka-ken
city: Iizuka-shi
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka-ken
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka-ken
city: Koriyama
country: Japan
facility: Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
state: Fukushima
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Hakodate-shi
country: Japan
facility: National Hospital Organization Hakodate National Hospital
state: Hokkai-do
city: Hakodate
country: Japan
facility: Hakodate City Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Teine Keijinkai Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Medical Center
state: Hokkaido
city: Himeji
country: Japan
facility: Hyogo Brain and Heart Center
state: Hyogo
city: Himeji
country: Japan
facility: Japanease Red Cross Society Himeji Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
city: Toride-shi
country: Japan
facility: Toride Kyodo General Hospital
state: Ibaraki
city: Kannonji
country: Japan
facility: Mitoyo General Hospital
state: Kagawa
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: MIE
city: Sendai-shi
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi-ken
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center Hospital
state: Osaka-fu
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Sakai-shi
country: Japan
facility: Sakai City Medical Center
state: Osaka
city: Yodogawa-ku
country: Japan
facility: Gokeikai Osaka Kaisei Hospital
state: Osaka
city: Kasukabe-shi
country: Japan
facility: Shuwa General Hospital
state: Saitama
city: Saitama-shi
country: Japan
facility: Saitama Medical Center Jichi Medical University
state: Saitama
city: Kusatsu-shi
country: Japan
facility: Kusatsu General Hospital
state: Shiga-ken
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu Rosai Hospital
state: Shizuoka
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Komatsushima
country: Japan
facility: Tokushima Red Cross Hospital
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chiyoda-Ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Yonago-shi
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Ube-city
country: Japan
facility: Ube-kohsan Central Hospital Corp.
state: Yamaguchi
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Chuo
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Hamanomachi Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Okayama
country: Japan
facility: Japanese Red Cross Okayama Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Toyama
country: Japan
facility: Toyama University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tsutsui H, Ito H, Kitakaze M, Komuro I, Murohara T, Izumi T, Sunagawa K, Yasumura Y, Yano M, Yamamoto K, Yoshikawa T, Tsutamoto T, Zhang J, Okayama A, Ichikawa Y, Kanmuri K, Matsuzaki M; J-EMPHASIS-HF Study Group. Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF). Circ J. 2017 Dec 25;82(1):148-158. doi: 10.1253/circj.CJ-17-0323. Epub 2017 Aug 19.