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Heart drug entresto under safety watch in kids

NCT ID NCT06659393

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 30 children aged 1 to 17 with chronic heart failure who are taking Entresto for the first time. Researchers will monitor for side effects like low blood pressure, high potassium, kidney problems, and dehydration over 52 weeks. The goal is to understand how safe the drug is in real-world use for kids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Japanese pediatric patients with chronic heart failure using Entresto Tablets and Granules

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto. 2. Patients who received Entresto for the first time under the indication of chronic heart failure 3. Pediatric patients aged 1 to \< 18 years old at the start of treatment with Entresto Exclusion criteria 1. Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study) 2. 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

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatric chronic heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Ōbu, Aichi-ken, 474 8710, Japan

  • Novartis Investigative Site

    RECRUITING

    Toyoake, Aichi-ken, 4701192, Japan

  • Novartis Investigative Site

    RECRUITING

    Kurume, Fukuoka, 830-0011, Japan

  • Novartis Investigative Site

    RECRUITING

    Kurume, Fukuoka, 830-8543, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    RECRUITING

    Tsukuba, Ibaraki, 3058576, Japan

  • Novartis Investigative Site

    RECRUITING

    Kawasaki, Kanagawa, 2168511, Japan

  • Novartis Investigative Site

    RECRUITING

    Yokohama, Kanagawa-ku, 236-0004, Japan

  • Novartis Investigative Site

    RECRUITING

    Tsu, Mie-ken, 514-8507, Japan

  • Novartis Investigative Site

    RECRUITING

    Nagasaki, Nagasaki, 852-8501, Japan

  • Novartis Investigative Site

    RECRUITING

    Ōmura, Nagasaki, 856-8562, Japan

  • Novartis Investigative Site

    RECRUITING

    Hidaka, Saitama, 350-1298, Japan

  • Novartis Investigative Site

    RECRUITING

    Saitama, Saitama, 330-8777, Japan

  • Novartis Investigative Site

    RECRUITING

    Hamamatsu, Shizuoka, 430-8558, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 113-8655, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Novartis Investigative Site

    RECRUITING

    Fuchū, Tokyo, 183-0003, Japan

  • Novartis Investigative Site

    RECRUITING

    Fuchū, Tokyo, 1838561, Japan

  • Novartis Investigative Site

    RECRUITING

    Ōta-ku, Tokyo, 143 8541, Japan

  • Novartis Investigative Site

    RECRUITING

    Setagaya-ku, Tokyo, 1578535, Japan

  • Novartis Investigative Site

    RECRUITING

    Shinagawa-ku, Tokyo, 1428666, Japan

  • Novartis Investigative Site

    RECRUITING

    Shinjuku Ku, Tokyo, 1628666, Japan

  • Novartis Investigative Site

    RECRUITING

    Toyama, Toyama, 9300194, Japan

  • Novartis Investigative Site

    RECRUITING

    Akita, 010-8543, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    COMPLETED

    Kumamoto, 862-8505, Japan

  • Novartis Investigative Site

    RECRUITING

    Okayama, 7008558, Japan

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