Special Drug Use Surveillance for Entresto Tablets

Special Drug Use Surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)

This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Drug: Entresto

Detailed Description

This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved indication of "chronic heart failure" and to be conducted as one of the RMP-specified additional pharmacovigilance activities.

• Study Type: Observational
• Enrollment (Actual): 688

Contacts and Locations

Study Locations

• Japan
  • Gifu, Japan, 500-8384
    • Novartis Investigative Site
  • Hiroshima, Japan, 731-0102
    • Novartis Investigative Site
  • Hiroshima, Japan, 731-0113
    • Novartis Investigative Site
  • Hiroshima, Japan, 731-0154
    • Novartis Investigative Site
  • Kumamoto, Japan, 861-4115
    • Novartis Investigative Site
  • Kumamoto, Japan, 862-0916
    • Novartis Investigative Site
  • Kumamoto, Japan, 862-0924
    • Novartis Investigative Site
  • Kyoto, Japan, 612-8555
    • Novartis Investigative Site
  • Nagasaki, Japan, 852-8055
    • Novartis Investigative Site
  • Oita, Japan, 870-0955
    • Novartis Investigative Site
  • Oita, Japan, 879-7761
    • Novartis Investigative Site
  • Osaka, Japan, 531-0071
    • Novartis Investigative Site
  • Osaka, Japan, 533-0001
    • Novartis Investigative Site
  • Osaka, Japan, 533-0013
    • Novartis Investigative Site
  • Osaka, Japan, 537-0024
    • Novartis Investigative Site
  • Saitama, Japan, 338-0837
    • Novartis Investigative Site
  • Shizuoka, Japan, 420-0867
    • Novartis Investigative Site
  • Tokushima, Japan, 770-8079
    • Novartis Investigative Site
  • Toyama, Japan, 939-8081
    • Novartis Investigative Site
  • Wakayama, Japan, 641-0006
    • Novartis Investigative Site
  • Yamaguchi, Japan, 754-0002
    • Novartis Investigative Site
  • Aichi
    • Ichinomiya, Aichi, Japan, 493-0004
      • Novartis Investigative Site
    • Ichinomiya, Aichi, Japan, 494-0001
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 460-0004
      • Novartis Investigative Site
    • Nishio, Aichi, Japan, 444-0403
      • Novartis Investigative Site
    • Obu, Aichi, Japan, 474-0044
      • Novartis Investigative Site
    • Yatomi, Aichi, Japan, 498-0048
      • Novartis Investigative Site
  • Chiba
    • Funabashi, Chiba, Japan, 273-0031
      • Novartis Investigative Site
    • Kashiwa, Chiba, Japan, 277-0054
      • Novartis Investigative Site
    • Sakura, Chiba, Japan, 285-8765
      • Novartis Investigative Site
    • Yachiyo-city, Chiba, Japan, 276-8524
      • Novartis Investigative Site
  • Ehime
    • Imabari, Ehime, Japan, 794-0052
      • Novartis Investigative Site
    • Matsuyama, Ehime, Japan, 790-0932
      • Novartis Investigative Site
  • Fukuka
    • Chikushino-city, Fukuka, Japan, 818-8516
      • Novartis Investigative Site
  • Fukuoka
    • Kasuya-gun, Fukuoka, Japan, 811-2311
      • Novartis Investigative Site
    • Ukiha, Fukuoka, Japan, 839-1306
      • Novartis Investigative Site
  • Fukushima
    • Iwaki, Fukushima, Japan, 979-0201
      • Novartis Investigative Site
  • Gunma
    • Maebashi, Gunma, Japan, 371-0004
      • Novartis Investigative Site
    • Takasaki, Gunma, Japan, 370-0046
      • Novartis Investigative Site
  • Hiroshima
    • Fuchu, Hiroshima, Japan, 726-0013
      • Novartis Investigative Site
    • Mihara, Hiroshima, Japan
      • Novartis Investigative Site
    • Takehara, Hiroshima, Japan, 725-0012
      • Novartis Investigative Site
    • Takehara, Hiroshima, Japan, 725-0026
      • Novartis Investigative Site
  • Hokkaido
    • Abashiri, Hokkaido, Japan, 092-0235
      • Novartis Investigative Site
    • Fukagawa, Hokkaido, Japan, 074-0006
      • Novartis Investigative Site
    • Hakodate, Hokkaido, Japan, 041-8522
      • Novartis Investigative Site
    • Ishikari, Hokkaido, Japan, 061-3217
      • Novartis Investigative Site
    • Iwamizawa, Hokkaido, Japan, 068-0004
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 004-0052
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 007-0849
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 065-0012
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 065-0027
      • Novartis Investigative Site
  • Hyogo
    • Akashi, Hyogo, Japan, 673-0023
      • Novartis Investigative Site
    • Awaji, Hyogo, Japan, 656-2131
      • Novartis Investigative Site
    • Himeji, Hyogo, Japan, 670-0811
      • Novartis Investigative Site
    • Himeji, Hyogo, Japan, 672-8035
      • Novartis Investigative Site
    • Kakogawa, Hyogo, Japan, 675-0017
      • Novartis Investigative Site
    • Kakogawa-city, Hyogo, Japan, 675-0101
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 654-0121
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 657-0051
      • Novartis Investigative Site
    • Kobe-city, Hyogo, Japan, 650-0047
      • Novartis Investigative Site
    • Nishinomiya, Hyogo, Japan, 663-8107
      • Novartis Investigative Site
    • Takarazuka-city, Hyogo, Japan, 665-0861
      • Novartis Investigative Site
    • Takarazuka-city, Hyogo, Japan, 665-0873
      • Novartis Investigative Site
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0004
      • Novartis Investigative Site
    • Mito, Ibaraki, Japan, 310-0841
      • Novartis Investigative Site
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-0007
      • Novartis Investigative Site
  • Iwate
    • Morioka, Iwate, Japan, 020-0871
      • Novartis Investigative Site
  • Kagawa
    • Takamatsu, Kagawa, Japan, 761-8063
      • Novartis Investigative Site
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 252-0802
      • Novartis Investigative Site
    • Kamakura, Kanagawa, Japan, 248-0011
      • Novartis Investigative Site
    • Sagamihara, Kanagawa, Japan, 252-0105
      • Novartis Investigative Site
    • Yokohama-city, Kanagawa, Japan, 236 0037
      • Novartis Investigative Site
  • Kyoto
    • Mukou-City, Kyoto, Japan, 617-0002
      • Novartis Investigative Site
  • Mie
    • Iga, Mie, Japan, 518-0121
      • Novartis Investigative Site
    • Tsu-City, Mie, Japan, 514-0823
      • Novartis Investigative Site
    • Tsu-city, Mie, Japan, 514-8508
      • Novartis Investigative Site
    • Watarai, Mie, Japan, 516-0101
      • Novartis Investigative Site
  • Miyagi
    • Higashimatsushima, Miyagi, Japan, 981-0501
      • Novartis Investigative Site
    • Shiogama, Miyagi, Japan, 985-0087
      • Novartis Investigative Site
  • Miyazaki
    • Saito, Miyazaki, Japan, 881-0003
      • Novartis Investigative Site
  • Nagasaki
    • Iki-city, Nagasaki, Japan, 811-5135
      • Novartis Investigative Site
    • Sasebo, Nagasaki, Japan, 857-0053
      • Novartis Investigative Site
  • Nara
    • Kita-Katsuragi-gun, Nara, Japan, 636-0002
      • Novartis Investigative Site
  • Okayama
    • Kurashiki, Okayama, Japan, 710-1101
      • Novartis Investigative Site
    • Kurashiki, Okayama, Japan, 713-8121
      • Novartis Investigative Site
  • Okinawa
    • Urasoe, Okinawa, Japan, 901-2132
      • Novartis Investigative Site
  • Osaka
    • Sakai, Osaka, Japan, 590-0111
      • Novartis Investigative Site
  • Saga
    • Kishima-gun, Saga, Japan, 849-0401
      • Novartis Investigative Site
    • Ureshino, Saga, Japan, 843-0302
      • Novartis Investigative Site
  • Saitama
    • Kawaguchi, Saitama, Japan, 332-0001
      • Novartis Investigative Site
    • Kawaguchi, Saitama, Japan, 333-0847
      • Novartis Investigative Site
    • Sayama, Saitama, Japan, 350-1305
      • Novartis Investigative Site
    • Toda, Saitama, Japan, 335-0013
      • Novartis Investigative Site
    • Tokorozawa, Saitama, Japan, 351-1151
      • Novartis Investigative Site
    • Tokorozawa, Saitama, Japan, 359-1142
      • Novartis Investigative Site
  • Shiga
    • Higashiohmi, Shiga, Japan, 527-0134
      • Novartis Investigative Site
  • Shizuoka
    • Gotenba, Shizuoka, Japan, 412-0043
      • Novartis Investigative Site
    • Hamamatsu, Shizuoka, Japan, 434-0011
      • Novartis Investigative Site
    • Sunto-gun, Shizuoka, Japan, 411-0917
      • Novartis Investigative Site
  • Tochigi
    • Nasushiobara, Tochigi, Japan, 329-2763
      • Novartis Investigative Site
    • Utsunomiya, Tochigi, Japan, 321-0917
      • Novartis Investigative Site
  • Tokyo
    • Adachi, Tokyo, Japan, 123-0845
      • Novartis Investigative Site
    • Adachi, Tokyo, Japan, 123-0864
      • Novartis Investigative Site
    • Akiruno, Tokyo, Japan, 197-0804
      • Novartis Investigative Site
    • Hachioji, Tokyo, Japan, 192-0046
      • Novartis Investigative Site
    • Hachioji-city, Tokyo, Japan, 192-0918
      • Novartis Investigative Site
    • Katsushika, Tokyo, Japan, 124-0021
      • Novartis Investigative Site
    • Machida, Tokyo, Japan, 194-0013
      • Novartis Investigative Site
    • Machida, Tokyo, Japan, 194-0043
      • Novartis Investigative Site
    • Machida, Tokyo, Japan, 195-0074
      • Novartis Investigative Site
    • Minato, Tokyo, Japan, 106-0031
      • Novartis Investigative Site
    • Minato-ku, Tokyo, Japan, 108-8329
      • Novartis Investigative Site
    • Nakano, Tokyo, Japan, 165-0022
      • Novartis Investigative Site
    • Ota, Tokyo, Japan, 144-0051
      • Novartis Investigative Site
    • Ota, Tokyo, Japan, 144-8501
      • Novartis Investigative Site
    • Toshima, Tokyo, Japan, 171-0033
      • Novartis Investigative Site
  • Toyama
    • Takaoka, Toyama, Japan, 939-1104
      • Novartis Investigative Site
  • Yamagata
    • Sakata-city, Yamagata, Japan, 998-8501
      • Novartis Investigative Site
    • Shinjo, Yamagata, Japan, 996-0035
      • Novartis Investigative Site
  • Yamaguchi
    • Shimonoseki, Yamaguchi, Japan, 759-6301
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Japanese patients using Entresto for the newly approved indication of "chronic heart failure"

Description

Inclusion Criteria:

• Patients must provide written consent to cooperate in this study before the start of Entresto
• Patients using Entresto for the first time for the following indication Indication: chronic heart failure patients on standard of care for chronic heart failure

Exclusion Criteria:

• Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto
• The following patients for whom Entresto is contraindicated in the package insert Patients with a history of hypersensitivity to any of the Entresto ingredients Patients with a history of angioedema (angiotensin II receptor blockers or angiotensin converting enzyme inhibitors-induced angioedema, hereditary angioedema, acquired angioedema, idiopathic angioedema etc.) Diabetic patients on aliskiren fumarate Patients with severe hepatic impairment (Child-Pugh class C) Pregnant or possibly pregnant women

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Entresto; Patients administered Entresto by prescription	Drug: Entresto; There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of Entresto in chronic heart failure patients	EAIR of hypotension, hyperkalemia, renal impairment and dehydration will be collected. EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the impact of risk factors	Subgroup analysis of EAIR (patients/100 patient-years) of hypotension, hyperkalemia, renal impairment and dehydration by risk factor will be presented EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients	Up to 52 weeks
To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs	A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal. An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Entresto or whose causality is not recorded	Up to 52 weeks
EAIR for each of the clinical events	EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients	Up to 52 weeks
Kaplan-Meier curve for each of the clinical events	Kaplan-Meier estimate of cumulative failure rate(%) will be collected	Up to 52 weeks
Total frequency of hospitalization due to heart failure	Total frequency of hospitalization due to heart failure will be collected	Up to 52 weeks
To investigate data on the administration of Entresto in clinical use	Data on Entresto administration will be collected	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Japan; chronic heart failure; sacubitril/valsartan; Entresto; sacubitril valsartan sodium hydrate
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Angiotensin Receptor Antagonists; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696B1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO