The Study is to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Phase 2

Conditions: Health Condition 1: I502- Systolic (congestive) heart failure

Registration Number: CTRI/2020/03/024164

Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.

2. Patient was on study medication at the PANORAMA-HF Part 2 End of Study visit (Visit 416) and does not have any significant safety issue as determined by the investigator. Based on the investigator judgement, the patient is able to safely enroll in the OLE study.

Exclusion Criteria

1. 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

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 more than or equal to 36-hour washout before baseline visit)

3. 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

4. Renal vascular hypertension (including renal artery stenosis)

5. Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula less than 30 percent mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase more than 3 times upper limit of normal); gastrointestinal disorder or biliary disorder

6. History of angioedema

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate safety and tolerability of sacubitril/valsartan in eligible PANORAMA-HF subjects receiving open-label sacubitril/valsartan.Timepoint: The study duration will be approximately 1 year from the date of the LPLV in the <br/ ><br>PANORAMA-HF study and approximately 3 years from the date of First Patient First Visit <br/ ><br>(FPFV) in the OLE. This timeframe will allow for meaningful capture of long-term safety data. <br/ ><br>In addition the results of the PANORAMA-HF study results will be available during this time <br/ ><br>frame and will determine whether patients in PANORAMA-HF derived benefit from treatment with LCZ696.

Secondary Outcome Measures