An Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With Heart Failure (HF)

Overview

Información sobre este estudio

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) pediatric patients receiving open-label sacubitril/valsartan.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Signed informed consent

- On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety
issue

Exclusion Criteria:

- Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or
permanently discontinued study drug in PANORMA-HF Part 2

- Use of investigational drugs within 5 half-lives of enrollment or within 30 days
(longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour
washout before baseline visit)

- History of hypersensitivity or allergy to study treatment, its excipients or drugs of
similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected
contraindications to sacubitril/valsartan

- Renal vascular hypertension (including renal artery stenosis)

- Significant renal estimated glomerular filtration rate disorder (eGFR calculated using
modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate
aminotransferase or alanine aminotransferase > 3 times upper limit of normal);
gastrointestinal disorder or biliary disorder

- History of angioedema

- Parents or legal guardians of subject who do not give consent or allow the child to
give assent, or inability of patient or parents/legal guardians to follow instructions
or comply with follow-up procedures

- Any medical condition(s) that may put the patient at risk in the investigator's
opinion or that the investigator deems unsuitable for the study

- Other protocol defined inclusion/exclusion criteria may apply

Eligibility last updated 7/26/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Jonathan Johnson, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20474324

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