Special Drug Use Surveillance for Entresto Tablets

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04781881

Collaborator

(none)

688

Enrollment

121

Locations

25.6

Anticipated Duration (Months)

5.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	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 Design

Study Type:

Observational

Actual Enrollment :

688 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 4, 2021

Anticipated Primary Completion Date :

Apr 21, 2023

Anticipated Study Completion Date :

Apr 21, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

To evaluate the safety of Entresto in chronic heart failure patients [Up to 52 weeks]
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

Secondary Outcome Measures

To evaluate the impact of risk factors [Up to 52 weeks]
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
To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs [Up to 52 weeks]
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
EAIR for each of the clinical events [Up to 52 weeks]
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
Kaplan-Meier curve for each of the clinical events [Up to 52 weeks]
Kaplan-Meier estimate of cumulative failure rate(%) will be collected
Total frequency of hospitalization due to heart failure [Up to 52 weeks]
Total frequency of hospitalization due to heart failure will be collected
To investigate data on the administration of Entresto in clinical use [Up to 52 weeks]
Data on Entresto administration will be collected

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Ichinomiya	Aichi	Japan	493-0004
2	Novartis Investigative Site	Ichinomiya	Aichi	Japan	494-0001
3	Novartis Investigative Site	Nagoya	Aichi	Japan	460-0004
4	Novartis Investigative Site	Nishio	Aichi	Japan	444-0403
5	Novartis Investigative Site	Obu	Aichi	Japan	474-0044
6	Novartis Investigative Site	Yatomi	Aichi	Japan	498-0048
7	Novartis Investigative Site	Funabashi	Chiba	Japan	273-0031
8	Novartis Investigative Site	Kashiwa	Chiba	Japan	277-0054
9	Novartis Investigative Site	Sakura	Chiba	Japan	285-8765
10	Novartis Investigative Site	Yachiyo-city	Chiba	Japan	276-8524
11	Novartis Investigative Site	Imabari	Ehime	Japan	794-0052
12	Novartis Investigative Site	Matsuyama	Ehime	Japan	790-0932
13	Novartis Investigative Site	Chikushino-city	Fukuka	Japan	818-8516
14	Novartis Investigative Site	Kasuya-gun	Fukuoka	Japan	811-2311
15	Novartis Investigative Site	Ukiha	Fukuoka	Japan	839-1306
16	Novartis Investigative Site	Iwaki	Fukushima	Japan	979-0201
17	Novartis Investigative Site	Maebashi	Gunma	Japan	371-0004
18	Novartis Investigative Site	Takasaki	Gunma	Japan	370-0046
19	Novartis Investigative Site	Fuchu	Hiroshima	Japan	726-0013
20	Novartis Investigative Site	Mihara	Hiroshima	Japan
21	Novartis Investigative Site	Takehara	Hiroshima	Japan	725-0012
22	Novartis Investigative Site	Takehara	Hiroshima	Japan	725-0026
23	Novartis Investigative Site	Abashiri	Hokkaido	Japan	092-0235
24	Novartis Investigative Site	Fukagawa	Hokkaido	Japan	074-0006
25	Novartis Investigative Site	Hakodate	Hokkaido	Japan	041-8522
26	Novartis Investigative Site	Ishikari	Hokkaido	Japan	061-3217
27	Novartis Investigative Site	Iwamizawa	Hokkaido	Japan	068-0004
28	Novartis Investigative Site	Sapporo	Hokkaido	Japan	004-0052
29	Novartis Investigative Site	Sapporo	Hokkaido	Japan	007-0849
30	Novartis Investigative Site	Sapporo	Hokkaido	Japan	065-0012
31	Novartis Investigative Site	Sapporo	Hokkaido	Japan	065-0027
32	Novartis Investigative Site	Akashi	Hyogo	Japan	673-0023
33	Novartis Investigative Site	Awaji	Hyogo	Japan	656-2131
34	Novartis Investigative Site	Himeji	Hyogo	Japan	670-0811
35	Novartis Investigative Site	Himeji	Hyogo	Japan	672-8035
36	Novartis Investigative Site	Kakogawa-city	Hyogo	Japan	675-0101
37	Novartis Investigative Site	Kakogawa	Hyogo	Japan	675-0017
38	Novartis Investigative Site	Kobe-city	Hyogo	Japan	650-0047
39	Novartis Investigative Site	Kobe	Hyogo	Japan	654-0121
40	Novartis Investigative Site	Kobe	Hyogo	Japan	657-0051
41	Novartis Investigative Site	Nishinomiya	Hyogo	Japan	663-8107
42	Novartis Investigative Site	Takarazuka-city	Hyogo	Japan	665-0861
43	Novartis Investigative Site	Takarazuka-city	Hyogo	Japan	665-0873
44	Novartis Investigative Site	Mito	Ibaraki	Japan	310-0004
45	Novartis Investigative Site	Mito	Ibaraki	Japan	310-0841
46	Novartis Investigative Site	Kanazawa	Ishikawa	Japan	920-0007
47	Novartis Investigative Site	Morioka	Iwate	Japan	020-0871
48	Novartis Investigative Site	Takamatsu	Kagawa	Japan	761-8063
49	Novartis Investigative Site	Fujisawa	Kanagawa	Japan	252-0802
50	Novartis Investigative Site	Kamakura	Kanagawa	Japan	248-0011
51	Novartis Investigative Site	Sagamihara	Kanagawa	Japan	252-0105
52	Novartis Investigative Site	Yokohama-city	Kanagawa	Japan	236 0037
53	Novartis Investigative Site	Mukou-City	Kyoto	Japan	617-0002
54	Novartis Investigative Site	Iga	Mie	Japan	518-0842
55	Novartis Investigative Site	Tsu-City	Mie	Japan	514-0823
56	Novartis Investigative Site	Tsu-city	Mie	Japan	514-8508
57	Novartis Investigative Site	Watarai	Mie	Japan	516-0101
58	Novartis Investigative Site	Higashimatsushima	Miyagi	Japan	981-0501
59	Novartis Investigative Site	Shiogama	Miyagi	Japan	985-0087
60	Novartis Investigative Site	Saito	Miyazaki	Japan	881-0003
61	Novartis Investigative Site	Iki-city	Nagasaki	Japan	811-5135
62	Novartis Investigative Site	Sasebo	Nagasaki	Japan	857-0053
63	Novartis Investigative Site	Kita-Katsuragi-gun	Nara	Japan	636-0002
64	Novartis Investigative Site	Kurashiki	Okayama	Japan	710-1101
65	Novartis Investigative Site	Kurashiki	Okayama	Japan	713-8121
66	Novartis Investigative Site	Urasoe	Okinawa	Japan	901-2132
67	Novartis Investigative Site	Sakai	Osaka	Japan	590-0111
68	Novartis Investigative Site	Kishima-gun	Saga	Japan	849-0401
69	Novartis Investigative Site	Ureshino	Saga	Japan	843-0302
70	Novartis Investigative Site	Kawaguchi	Saitama	Japan	332-0001
71	Novartis Investigative Site	Kawaguchi	Saitama	Japan	333-0847
72	Novartis Investigative Site	Sayama	Saitama	Japan	350-1305
73	Novartis Investigative Site	Toda	Saitama	Japan	335-0013
74	Novartis Investigative Site	Tokorozawa	Saitama	Japan	351-1151
75	Novartis Investigative Site	Tokorozawa	Saitama	Japan	359-1142
76	Novartis Investigative Site	Higashiohmi	Shiga	Japan	527-0134
77	Novartis Investigative Site	Gotenba	Shizuoka	Japan	412-0043
78	Novartis Investigative Site	Hamamatsu	Shizuoka	Japan	434-0011
79	Novartis Investigative Site	Sunto-gun	Shizuoka	Japan	411-0917
80	Novartis Investigative Site	Nasushiobara	Tochigi	Japan	329-2763
81	Novartis Investigative Site	Utsunomiya	Tochigi	Japan	321-0917
82	Novartis Investigative Site	Adachi	Tokyo	Japan	123-0845
83	Novartis Investigative Site	Adachi	Tokyo	Japan	123-0864
84	Novartis Investigative Site	Akiruno	Tokyo	Japan	197-0804
85	Novartis Investigative Site	Hachioji-city	Tokyo	Japan	192-0918
86	Novartis Investigative Site	Hachioji	Tokyo	Japan	192-0046
87	Novartis Investigative Site	Katsushika	Tokyo	Japan	124-0021
88	Novartis Investigative Site	Machida	Tokyo	Japan	194-0013
89	Novartis Investigative Site	Machida	Tokyo	Japan	194-0043
90	Novartis Investigative Site	Machida	Tokyo	Japan	195-0074
91	Novartis Investigative Site	Minato-ku	Tokyo	Japan	108-8329
92	Novartis Investigative Site	Minato	Tokyo	Japan	106-0031
93	Novartis Investigative Site	Nakano	Tokyo	Japan	165-0022
94	Novartis Investigative Site	Ota	Tokyo	Japan	144-0051
95	Novartis Investigative Site	Ota	Tokyo	Japan	144-8501
96	Novartis Investigative Site	Toshima	Tokyo	Japan	171-0033
97	Novartis Investigative Site	Takaoka	Toyama	Japan	939-1104
98	Novartis Investigative Site	Sakata-city	Yamagata	Japan	998-8501
99	Novartis Investigative Site	Shinjo	Yamagata	Japan	996-0035
100	Novartis Investigative Site	Shimonoseki	Yamaguchi	Japan	759-6301
101	Novartis Investigative Site	Gifu		Japan	500-8384
102	Novartis Investigative Site	Hiroshima		Japan	731-0102
103	Novartis Investigative Site	Hiroshima		Japan	731-0113
104	Novartis Investigative Site	Hiroshima		Japan	731-0154
105	Novartis Investigative Site	Kumamoto		Japan	861-4115
106	Novartis Investigative Site	Kumamoto		Japan	862-0916
107	Novartis Investigative Site	Kumamoto		Japan	862-0924
108	Novartis Investigative Site	Kyoto		Japan	612-8555
109	Novartis Investigative Site	Nagasaki		Japan	852-8055
110	Novartis Investigative Site	Oita		Japan	870-0955
111	Novartis Investigative Site	Oita		Japan	879-7761
112	Novartis Investigative Site	Osaka		Japan	531-0071
113	Novartis Investigative Site	Osaka		Japan	533-0001
114	Novartis Investigative Site	Osaka		Japan	533-0013
115	Novartis Investigative Site	Osaka		Japan	537-0024
116	Novartis Investigative Site	Saitama		Japan	338-0837
117	Novartis Investigative Site	Shizuoka		Japan	420-0867
118	Novartis Investigative Site	Tokushima		Japan	770-8079
119	Novartis Investigative Site	Toyama		Japan	939-8081
120	Novartis Investigative Site	Wakayama		Japan	641-0006
121	Novartis Investigative Site	Yamaguchi		Japan	754-0002