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Chronic Heart FailureNCT04781881

Special Drug Use Surveillance for Entresto Tablets

An observational study of Chronic Heart Failure, run by Novartis Pharmaceuticals at 121 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages Up to 99 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
Entresto
How many people
688 participants
Where
121 sitesJapan
Study dates
4 Mar 2021to 21 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

Japan121 sites

  • Novartis Investigative Site

    Abashiri, Hokkaido, 092-0235

  • Novartis Investigative Site

    Adachi City, Tokyo, 123-0845

  • Novartis Investigative Site

    Adachi City, Tokyo, 123-0864

  • Novartis Investigative Site

    Akashi, Hyōgo, 673-0023

  • Novartis Investigative Site

    Akiruno, Tokyo, 197-0804

  • Novartis Investigative Site

    Awaji, Hyōgo, 656-2131

  • Novartis Investigative Site

    Chikushino-shi, Fukuka, 818-8516

  • Novartis Investigative Site

    Fuchū, Hiroshima, 726-0013

  • Novartis Investigative Site

    Fujisawa, Kanagawa, 252-0802

  • Novartis Investigative Site

    Fukagawa, Hokkaido, 074-0006

  • Novartis Investigative Site

    Funabashi, Chiba, 273-0031

  • Novartis Investigative Site

    Gifu, 500-8384

  • Novartis Investigative Site

    Gotemba, Shizuoka, 412-0043

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0046

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0918

  • Novartis Investigative Site

    Hakodate, Hokkaido, 041-8522

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 434-0011

  • Novartis Investigative Site

    Higashimatsushima, Miyagi, 981-0501

  • Novartis Investigative Site

    Higashiohmi, Shiga, 527-0134

  • Novartis Investigative Site

    Himeji, Hyōgo, 670-0811

  • Novartis Investigative Site

    Himeji, Hyōgo, 672-8035

  • Novartis Investigative Site

    Hiroshima, 731-0102

  • Novartis Investigative Site

    Hiroshima, 731-0113

  • Novartis Investigative Site

    Hiroshima, 731-0154

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 493-0004

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 494-0001

  • Novartis Investigative Site

    Iga, Mie-ken, 518-0121

  • Novartis Investigative Site

    Iki, Nagasaki, 811-5135

  • Novartis Investigative Site

    Imabari, Ehime, 794-0052

  • Novartis Investigative Site

    Ishikari, Hokkaido, 061-3217

  • Novartis Investigative Site

    Iwaki, Fukushima, 979-0201

  • Novartis Investigative Site

    Iwamizawa, Hokkaido, 068-0004

  • Novartis Investigative Site

    Kakogawa, Hyōgo, 675-0017

  • Novartis Investigative Site

    Kakogawa, Hyōgo, 675-0101

  • Novartis Investigative Site

    Kamakura, Kanagawa, 248-0011

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920-0007

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-0054

  • Novartis Investigative Site

    Kasuya-gun, Fukuoka, 811-2311

  • Novartis Investigative Site

    Katsushika-ku, Tokyo, 124-0021

  • Novartis Investigative Site

    Kawaguchi, Saitama, 332-0001

  • Novartis Investigative Site

    Kawaguchi, Saitama, 333-0847

  • Novartis Investigative Site

    Kishima-gun, Saga-ken, 849-0401

  • Novartis Investigative Site

    Kita-Katsuragi-gun, Nara, 636-0002

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047

  • Novartis Investigative Site

    Kobe, Hyōgo, 654-0121

  • Novartis Investigative Site

    Kobe, Hyōgo, 657-0051

  • Novartis Investigative Site

    Kumamoto, 861-4115

  • Novartis Investigative Site

    Kumamoto, 862-0916

  • Novartis Investigative Site

    Kumamoto, 862-0924

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 710-1101

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 713-8121

  • Novartis Investigative Site

    Kyoto, 612-8555

  • Novartis Investigative Site

    Machida, Tokyo, 194-0013

  • Novartis Investigative Site

    Machida, Tokyo, 194-0043

  • Novartis Investigative Site

    Machida, Tokyo, 195-0074

  • Novartis Investigative Site

    Maebashi, Gunma, 371-0004

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-0932

  • Novartis Investigative Site

    Mihara, Hiroshima

  • Novartis Investigative Site

    Minato, Tokyo, 106-0031

  • Novartis Investigative Site

    Minato-ku, Tokyo, 108-8329

  • Novartis Investigative Site

    Mito, Ibaraki, 310-0004

  • Novartis Investigative Site

    Mito, Ibaraki, 310-0841

  • Novartis Investigative Site

    Morioka, Iwate, 020-0871

  • Novartis Investigative Site

    Mukou-City, Kyoto, 617-0002

  • Novartis Investigative Site

    Nagasaki, 852-8055

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 460-0004

  • Novartis Investigative Site

    Nakano City, Tokyo, 165-0022

  • Novartis Investigative Site

    Nasushiobara, Tochigi, 329-2763

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663-8107

  • Novartis Investigative Site

    Nishio, Aichi-ken, 444-0403

  • Novartis Investigative Site

    Ōbu, Aichi-ken, 474-0044

  • Novartis Investigative Site

    Ōita, 870-0955

  • Novartis Investigative Site

    Ōita, 879-7761

  • Novartis Investigative Site

    Osaka, 531-0071

  • Novartis Investigative Site

    Osaka, 533-0001

  • Novartis Investigative Site

    Osaka, 533-0013

  • Novartis Investigative Site

    Osaka, 537-0024

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 144-0051

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 144-8501

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 252-0105

  • Novartis Investigative Site

    Saitama, 338-0837

  • Novartis Investigative Site

    Saito, Miyazaki, 881-0003

  • Novartis Investigative Site

    Sakai, Osaka, 590-0111

  • Novartis Investigative Site

    Sakata, Yamagata, 998-8501

  • Novartis Investigative Site

    Sakura, Chiba, 285-8765

  • Novartis Investigative Site

    Sapporo, Hokkaido, 004-0052

  • Novartis Investigative Site

    Sapporo, Hokkaido, 007-0849

  • Novartis Investigative Site

    Sapporo, Hokkaido, 065-0012

  • Novartis Investigative Site

    Sapporo, Hokkaido, 065-0027

  • Novartis Investigative Site

    Sasebo, Nagasaki, 857-0053

  • Novartis Investigative Site

    Sayama, Saitama, 350-1305

  • Novartis Investigative Site

    Shimonoseki, Yamaguchi, 759-6301

  • Novartis Investigative Site

    Shinjō, Yamagata, 996-0035

  • Novartis Investigative Site

    Shiogama, Miyagi, 985-0087

  • Novartis Investigative Site

    Shizuoka, 420-0867

  • Novartis Investigative Site

    Sunto-gun, Shizuoka, 411-0917

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 761-8063

  • Novartis Investigative Site

    Takaoka, Toyama, 939-1104

  • Novartis Investigative Site

    Takarazuka, Hyōgo, 665-0861

  • Novartis Investigative Site

    Takarazuka, Hyōgo, 665-0873

  • Novartis Investigative Site

    Takasaki, Gunma, 370-0046

  • Novartis Investigative Site

    Takehara, Hiroshima, 725-0012

  • Novartis Investigative Site

    Takehara, Hiroshima, 725-0026

  • Novartis Investigative Site

    Tamaru, Mie-ken, 516-0101

  • Novartis Investigative Site

    Toda, Saitama, 335-0013

  • Novartis Investigative Site

    Tokorozawa, Saitama, 351-1151

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-1142

  • Novartis Investigative Site

    Tokushima, 770-8079

  • Novartis Investigative Site

    Toshima City, Tokyo, 171-0033

  • Novartis Investigative Site

    Toyama, 939-8081

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-0823

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-8508

  • Novartis Investigative Site

    Ukiha, Fukuoka, 839-1306

  • Novartis Investigative Site

    Urasoe, Okinawa, 901-2132

  • Novartis Investigative Site

    Ureshino, Saga-ken, 843-0302

  • Novartis Investigative Site

    Utsunomiya, Tochigi, 321-0917

  • Novartis Investigative Site

    Wakayama, 641-0006

  • Novartis Investigative Site

    Yachiyo, Chiba, 276-8524

  • Novartis Investigative Site

    Yamaguchi, 754-0002

  • Novartis Investigative Site

    Yatomi, Aichi-ken, 498-0048

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236 0037

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Being tested
Entresto
Keywords
chronic heart failure, Entresto, Japan, sacubitril/valsartan, sacubitril valsartan sodium hydrate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntrestoDrug

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

Study groups in NCT04781881
Study groupRoleWhat they receive
EntrestoPatients administered Entresto by prescription
Receives: Drug: Entresto

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 52 weeks

Secondary outcomes (6)

  1. 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

    Measured: Up to 52 weeks

  2. 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

    Measured: Up to 52 weeks

  3. 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

    Measured: Up to 52 weeks

  4. Kaplan-Meier curve for each of the clinical events

    Kaplan-Meier estimate of cumulative failure rate(%) will be collected

    Measured: Up to 52 weeks

  5. Total frequency of hospitalization due to heart failure

    Total frequency of hospitalization due to heart failure will be collected

    Measured: Up to 52 weeks

  6. To investigate data on the administration of Entresto in clinical use

    Data on Entresto administration will be collected

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start4 Mar 2021
  3. Primary completion21 Apr 2023
  4. Study completion21 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781881
Sponsor's protocol ID
CLCZ696B1401
Status last verified
May 2023
First submitted
1 Mar 2021
Last updated
6 May 2023
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure, run by Novartis Pharmaceuticals at 121 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety of Entresto in chronic heart failure patients (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04781881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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