Pediatric Chronic Heart FailureNCT06659393
Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)
An observational study of Pediatric Chronic Heart Failure, run by Novartis Pharmaceuticals at 28 sites in Japan.
Trial summary
This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pediatric Chronic Heart Failure
- How many people
- 30 participants
- Where
- 28 sitesJapan
- Study dates
- 19 Dec 2024to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Japanese pediatric patients with chronic heart failure using Entresto Tablets and Granules
Who may be able to join
- Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
- Patients who received Entresto for the first time under the indication of chronic heart failure
- Pediatric patients aged 1 to < 18 years old at the start of treatment with Entresto
Who cannot join
- Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
- Patients for whom Entresto is contraindicated according to the package insert
- Patients with a history of hypersensitivity to any ingredients of Entresto
- Patients currently under treatment with angiotensin-converting enzyme inhibitors or within 36 hours of discontinuation of treatment with angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, lisinopril hydrate).
- Patients with a history of angioedema (including angioedema due to angiotensin II receptor blockers or angiotensin-converting enzyme inhibitors, hereditary angioedema, acquired angioedema, and idiopathic angioedema etc.)
- Patients with diabetes mellitus under treatment with aliskiren fumarate (excluding patients with markedly poorly controlled blood pressure despite other antihypertensive therapies)
- Patients with severe hepatic impairment (Child-Pugh class C)
- Pregnant women or women who may be pregnant
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
28 sites in 1 country
Japan28 sites, 26 recruiting
- Recruiting
Novartis Investigative Site
Akita, 010-8543
- Recruiting
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113-8655
- Recruiting
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138431
- Recruiting
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8603
- Recruiting
Novartis Investigative Site
Fuchū, Tokyo, 183-0003
- Recruiting
Novartis Investigative Site
Fuchū, Tokyo, 1838561
- Active, not recruiting
Novartis Investigative Site
Fukuoka, 8128582
- Recruiting
Novartis Investigative Site
Hamamatsu, Shizuoka, 430-8558
- Recruiting
Novartis Investigative Site
Hidaka, Saitama, 350-1298
- Recruiting
Novartis Investigative Site
Kawasaki, Kanagawa, 2168511
- Completed
Novartis Investigative Site
Kumamoto, 862-8505
- Recruiting
Novartis Investigative Site
Kurume, Fukuoka, 830-0011
- Recruiting
Novartis Investigative Site
Kurume, Fukuoka, 830-8543
- Recruiting
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8501
- Recruiting
Novartis Investigative Site
Ōbu, Aichi-ken, 474 8710
- Recruiting
Novartis Investigative Site
Okayama, 7008558
- Recruiting
Novartis Investigative Site
Ōmura, Nagasaki, 856-8562
- Recruiting
Novartis Investigative Site
Ōta-ku, Tokyo, 143 8541
- Recruiting
Novartis Investigative Site
Saitama, Saitama, 330-8777
- Recruiting
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
- Recruiting
Novartis Investigative Site
Setagaya-ku, Tokyo, 1578535
- Recruiting
Novartis Investigative Site
Shinagawa-ku, Tokyo, 1428666
- Recruiting
Novartis Investigative Site
Shinjuku Ku, Tokyo, 1628666
- Recruiting
Novartis Investigative Site
Toyama, Toyama, 9300194
- Recruiting
Novartis Investigative Site
Toyoake, Aichi-ken, 4701192
- Recruiting
Novartis Investigative Site
Tsu, Mie-ken, 514-8507
- Recruiting
Novartis Investigative Site
Tsukuba, Ibaraki, 3058576
- Recruiting
Novartis Investigative Site
Yokohama, Kanagawa-ku, 236-0004
About this study
Official title: Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401)
This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration.
Read the detailed description
This specified drug-use survey is conducted to collect information on the safety specifications of Entresto in pediatric patients with chronic heart failure in Japan in actual clinical settings, and to investigate the occurrence of events related to the safety specifications, the risk factors associated with these events, and the status of Entresto administration including the accidental administration of capsule-shaped container (Granules for Pediatric). The subjects of this study are pediatric patients and a long-term observation of 1 year (52 weeks) has been set.
- Conditions
- Pediatric Chronic Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration
To confirm the occurrence status up to 52 weeks of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications of Entresto administration in pediatric patients with chronic heart failure in actual clinical settings.
Measured: one year
Secondary outcomes (4)
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors
To investigate the impact of risk factors on the occurrence of hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications.
Measured: one year
Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric)
To confirm the occurrence status of the accidental administration of the capsule-shaped container (Granules for Pediatric).
Measured: one year
Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions
To confirm the occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions.
Measured: one year
Administration status of Entresto during the observation period
To confirm the administration status of Entresto used in actual clinical settings.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start19 Dec 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659393
- Sponsor's protocol ID
- CLCZ696F1401
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401)
- ClinicalTrials.gov ID
- NCT06659393
- Acronym / sponsor ID
- CLCZ696F1401
- Conditions
- Pediatric Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration.
Detailed description
This specified drug-use survey is conducted to collect information on the safety specifications of Entresto in pediatric patients with chronic heart failure in Japan in actual clinical settings, and to investigate the occurrence of events related to the safety specifications, the risk factors associated with these events, and the status of Entresto administration including the accidental administration of capsule-shaped container (Granules for Pediatric). The subjects of this study are pediatric patients and a long-term observation of 1 year (52 weeks) has been set.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Japanese pediatric patients with chronic heart failure using Entresto Tablets and Granules
Key inclusion criteria (3 listed)
- Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
- Patients who received Entresto for the first time under the indication of chronic heart failure
- Pediatric patients aged 1 to < 18 years old at the start of treatment with Entresto
Key exclusion criteria (8 listed)
- Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
- Patients for whom Entresto is contraindicated according to the package insert
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration
Time frame: one year
To confirm the occurrence status up to 52 weeks of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications of Entresto administration in pediatric patients with chronic heart failure in actual clinical settings.
4 secondary outcomes
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors
Time frame: one year
Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric)
Time frame: one year
Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions
Time frame: one year
Administration status of Entresto during the observation period
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Chronic Heart Failure, run by Novartis Pharmaceuticals at 28 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+81337978748, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.