Clinical trial NCT06659393: Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)
Official title: Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Chronic Heart Failure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese pediatric patients with chronic heart failure using Entresto Tablets and Granules

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration
timeFrame: one year
Secondary outcomes:
measure: Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors
timeFrame: one year
measure: Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric)
timeFrame: one year
measure: Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions
timeFrame: one year
measure: Administration status of Entresto during the observation period
timeFrame: one year
Other outcomes:
Locations:
city: Obu
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Tsu-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Nagasaki-city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Omura
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Hidaka
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fuchu-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fuchu-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Akita
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
Study officials:
References: