SAFETY AND TOLERABILITY DURING OPEN-LABEL TREATMENT WITH LCZ696 IN PATIENTS WITH CHRONIC HEART FAILURE AND REDUCED EJECTION FRACTION

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-034-15
• Date of registration: 30/12/2015
• Prospective Registration: No
• Primary sponsor: NOVARTIS BIOSCIENSES PERU S.A.,
• Public title: SAFETY AND TOLERABILITY DURING OPEN-LABEL TREATMENT WITH LCZ696 IN PATIENTS WITH CHRONIC HEART FAILURE AND REDUCED EJECTION FRACTION
• Scientific title: A MULTICENTER STUDY TO EVALUATE SAFETY AND TOLERABILITY IN PATIENTS WITH CHRONIC HEART FAILURE AND REDUCED EJECTION FRACTION FROM PARADIGM-HF RECEIVING OPEN LABEL LCZ696
• Date of first enrolment: 19/10/2015
• Target sample size: 116
• Recruitment status: Recruiting
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=034-15
• Study type: Interventional
• Study design: This trial is a multicenter, open-label follow-up to PARADIGM-HF, which was a doubleblind; parallel treatment study that evaluated the morbidity, mortality and safety of LCZ696; compared to enalapril in patients with chronic heart failure and reduced ejection fraction.; Investigators for PARADIGM-HF have been informed of the study’s early closure and will be; offered the option to initiate treatment with LCZ696 for any eligible patient. For all; consenting patients, visits to dispense study drug and assess safety will be conducted at; baseline and at 6-month intervals (except for the first 3-4 weeks required for the up-titration; step and the 3-month visit) until conclusion of the trial.
• Phase: III

Countries of recruitment

Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Guatemala, Hungary, India, Israel, Italy, Japan, Korea North, Korea South, Latvia, Malasya, Mexico, Panama, Peru, Portugal, Russian Federation, Singapore, Sweden, Switzerland, Thailand, United Kindgdom, United States, Venezuela

Contacts

• Name: Karim Luque Luque
• Affiliation: NOVARTIS BIOSCIENCES PERU S.A.

• Name: Jimena Corre Correa
• Affiliation: NOVARTIS BIOSCIENCES PERU S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent for the extension must be obtained before any assessment is performed.
2. Patients who have completed PARADIGM-HF and are able to safely transition into the open-label study as judged by the investigator.

Exclusion criteria:
1. Any condition that in the opinion of the investigator is likely
to prevent the patient from safely tolerating LCZ696 or
complying with the requirements of the study.


Age minimum: 18
Age maximum: 99
Gender: Both

Health Condition(s) or Problem(s) studied

-I50

I50

Intervention(s)

This trial is a multicenter, open-label follow-up to PARADIGMHF, which evaluated the morbidity, mortality and safety of LCZ696 compared to enalapril in patients with chronic heart failure and reduced ejection fraction. Prior to enrollment in this
trial, all patients will have completed the PARADIGM-HF study and most will have transitioned to an ACEI or ARB. Investigators will be offered the option to initiate open-label treatment with LCZ696 for any PARADIGM-HF patient that meets the eligibility
criteria. Consenting patients will undergo a washout period, if necessary (36 hr for patients on ACEIs only), be up-titrated to the maximally tolerated dose of LCZ696 and scheduled for visits to
dispense study drug and assess safety and tolerability at 6-month intervals until the conclusion of the trial. Population All surviving patients that were randomized in PARADIGM-HF can be considered for eligibility in this open-label study
(CLCZ6962317). It is estimated that 5,000 patients (about 59% of the core study population and approximately 72% of the surviving patients) who meet the eligibility criteria will be enrolled into this
open-label trial.

Source(s) of Monetary Support

NOVARTIS BIOSCIENSES PERU S.A.

Ethics review

Status: Approved
Approval date: 16/03/2015
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 27/11/2015
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Status: Approved
Approval date: 27/05/2016
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Status: Approved
Approval date: 06/09/2016
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 27/09/2016
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 04/10/2016
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Results

• Results available: Yes
• Date Completed: 18/12/2017