Special Drug Use Surveillance for Entresto Tablets

NCT04781881 | Completed

• 1 other identifier: CLCZ696B1401
• Study Type: observational
• Target: 688
• Locations: 1 country
• Sites: 121

Brief Summary

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

Conditions

Chronic Heart Failure

Keywords

chronic heart failure; Entresto; Japan; sacubitril/valsartan; sacubitril valsartan sodium hydrate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• To evaluate the impact of risk factors

  Up to 52 weeks

• To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs

  Up to 52 weeks

• EAIR for each of the clinical events

  Up to 52 weeks

• Kaplan-Meier curve for each of the clinical events

  Up to 52 weeks

• Total frequency of hospitalization due to heart failure

  Up to 52 weeks

Study Arms (1)

Entresto

Patients administered Entresto by prescription

Drug: Entresto

Interventions

Entresto DRUG

There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.

Entresto

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (121)

Novartis Investigative Site

Ichinomiya, Aichi-ken, 493-0004, Japan

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Ichinomiya, Aichi-ken, 494-0001, Japan

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Nagoya, Aichi-ken, 460-0004, Japan

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Nishio, Aichi-ken, 444-0403, Japan

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Ōbu, Aichi-ken, 474-0044, Japan

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Yatomi, Aichi-ken, 498-0048, Japan

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Funabashi, Chiba, 273-0031, Japan

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Kashiwa, Chiba, 277-0054, Japan

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Sakura, Chiba, 285-8765, Japan

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Yachiyo, Chiba, 276-8524, Japan

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Imabari, Ehime, 794-0052, Japan

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Matsuyama, Ehime, 790-0932, Japan

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Chikushino-shi, Fukuka, 818-8516, Japan

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Kasuya-gun, Fukuoka, 811-2311, Japan

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Ukiha, Fukuoka, 839-1306, Japan

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Iwaki, Fukushima, 979-0201, Japan

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Maebashi, Gunma, 371-0004, Japan

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Takasaki, Gunma, 370-0046, Japan

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Fuchū, Hiroshima, 726-0013, Japan

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Mihara, Hiroshima, Japan

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Takehara, Hiroshima, 725-0012, Japan

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Takehara, Hiroshima, 725-0026, Japan

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Abashiri, Hokkaido, 092-0235, Japan

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Fukagawa, Hokkaido, 074-0006, Japan

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Hakodate, Hokkaido, 041-8522, Japan

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Ishikari, Hokkaido, 061-3217, Japan

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Iwamizawa, Hokkaido, 068-0004, Japan

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Sapporo, Hokkaido, 004-0052, Japan

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Sapporo, Hokkaido, 007-0849, Japan

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Sapporo, Hokkaido, 065-0012, Japan

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Sapporo, Hokkaido, 065-0027, Japan

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Akashi, Hyōgo, 673-0023, Japan

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Awaji, Hyōgo, 656-2131, Japan

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Himeji, Hyōgo, 670-0811, Japan

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Himeji, Hyōgo, 672-8035, Japan

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Kakogawa, Hyōgo, 675-0017, Japan

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Kakogawa, Hyōgo, 675-0101, Japan

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Kobe, Hyōgo, 650-0047, Japan

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Kobe, Hyōgo, 654-0121, Japan

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Kobe, Hyōgo, 657-0051, Japan

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Nishinomiya, Hyōgo, 663-8107, Japan

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Takarazuka, Hyōgo, 665-0861, Japan

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Takarazuka, Hyōgo, 665-0873, Japan

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Mito, Ibaraki, 310-0004, Japan

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Mito, Ibaraki, 310-0841, Japan

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Kanazawa, Ishikawa-ken, 920-0007, Japan

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Morioka, Iwate, 020-0871, Japan

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Takamatsu, Kagawa-ken, 761-8063, Japan

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Fujisawa, Kanagawa, 252-0802, Japan

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Kamakura, Kanagawa, 248-0011, Japan

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Sagamihara, Kanagawa, 252-0105, Japan

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Yokohama, Kanagawa, 236 0037, Japan

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Mukou-City, Kyoto, 617-0002, Japan

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Iga, Mie-ken, 518-0121, Japan

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Tamaru, Mie-ken, 516-0101, Japan

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Tsu, Mie-ken, 514-0823, Japan

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Tsu, Mie-ken, 514-8508, Japan

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Higashimatsushima, Miyagi, 981-0501, Japan

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Shiogama, Miyagi, 985-0087, Japan

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Saito, Miyazaki, 881-0003, Japan

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Iki, Nagasaki, 811-5135, Japan

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Sasebo, Nagasaki, 857-0053, Japan

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Kita-Katsuragi-gun, Nara, 636-0002, Japan

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Kurashiki, Okayama-ken, 710-1101, Japan

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Kurashiki, Okayama-ken, 713-8121, Japan

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Urasoe, Okinawa, 901-2132, Japan

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Sakai, Osaka, 590-0111, Japan

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Kishima-gun, Saga-ken, 849-0401, Japan

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Ureshino, Saga-ken, 843-0302, Japan

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Kawaguchi, Saitama, 332-0001, Japan

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Kawaguchi, Saitama, 333-0847, Japan

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Sayama, Saitama, 350-1305, Japan

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Toda, Saitama, 335-0013, Japan

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Tokorozawa, Saitama, 351-1151, Japan

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Tokorozawa, Saitama, 359-1142, Japan

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Higashiohmi, Shiga, 527-0134, Japan

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Gotemba, Shizuoka, 412-0043, Japan

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Hamamatsu, Shizuoka, 434-0011, Japan

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Sunto-gun, Shizuoka, 411-0917, Japan

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Nasushiobara, Tochigi, 329-2763, Japan

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Utsunomiya, Tochigi, 321-0917, Japan

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Adachi City, Tokyo, 123-0845, Japan

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Adachi City, Tokyo, 123-0864, Japan

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Akiruno, Tokyo, 197-0804, Japan

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Hachiōji, Tokyo, 192-0046, Japan

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Hachiōji, Tokyo, 192-0918, Japan

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Katsushika-ku, Tokyo, 124-0021, Japan

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Machida, Tokyo, 194-0013, Japan

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Machida, Tokyo, 194-0043, Japan

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Machida, Tokyo, 195-0074, Japan

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Minato, Tokyo, 106-0031, Japan

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Minato-ku, Tokyo, 108-8329, Japan

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Nakano City, Tokyo, 165-0022, Japan

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Ōta-ku, Tokyo, 144-0051, Japan

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Ōta-ku, Tokyo, 144-8501, Japan

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Toshima City, Tokyo, 171-0033, Japan

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Takaoka, Toyama, 939-1104, Japan

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Sakata, Yamagata, 998-8501, Japan

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Shinjō, Yamagata, 996-0035, Japan

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Shimonoseki, Yamaguchi, 759-6301, Japan

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Gifu, 500-8384, Japan

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Hiroshima, 731-0102, Japan

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Hiroshima, 731-0113, Japan

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Hiroshima, 731-0154, Japan

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Kumamoto, 861-4115, Japan

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Kumamoto, 862-0916, Japan

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Kumamoto, 862-0924, Japan

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Kyoto, 612-8555, Japan

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Nagasaki, 852-8055, Japan

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Osaka, 531-0071, Japan

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Osaka, 533-0001, Japan

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Osaka, 533-0013, Japan

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Osaka, 537-0024, Japan

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Ōita, 870-0955, Japan

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Ōita, 879-7761, Japan

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Saitama, 338-0837, Japan

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Shizuoka, 420-0867, Japan

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Tokushima, 770-8079, Japan

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Toyama, 939-8081, Japan

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Wakayama, 641-0006, Japan

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Yamaguchi, 754-0002, Japan

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MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: March 4, 2021
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (121)