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Angiotensin Receptor Neprilysin Inhibitor
Long-term Safety of Sacubitril/Valsartan for Heart Failure
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to end of study, up to 3 years
Awards & highlights
Study Summary
This trial looks at the long-term safety and tolerability of a heart failure drug.
Who is the study for?
This trial is for pediatric patients with heart failure who were previously on the PANORAMA-HF study drug at the end of its second part and had no significant safety issues. It excludes those with certain allergies, renal or hepatic disorders, a history of angioedema, or who used other investigational drugs recently.Check my eligibility
What is being tested?
The trial is testing sacubitril/valsartan's long-term safety in children with heart failure. Participants will receive this medication openly to gather extended safety and tolerability data following their involvement in the PANORAMA-HF study.See study design
What are the potential side effects?
Potential side effects may include allergic reactions, changes in kidney function, liver enzyme elevations, digestive disturbances, and possible swelling under the skin (angioedema), similar to what adults might experience.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ to end of study, up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to end of study, up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability
Side effects data
From 2019 Phase 3 trial • 2572 Patients • NCT0306680412%
Glomerular filtration rate decreased
11%
Hyperkalaemia
9%
Renal impairment
8%
Urine albumin/creatinine ratio increased
8%
Haematuria
7%
Proteinuria
6%
Hypertension
5%
Nasopharyngitis
5%
Urine protein/creatinine ratio increased
5%
Dizziness
5%
Hypotension
4%
Dyspnoea
3%
Atrial fibrillation
3%
Oedema peripheral
3%
Bronchitis
3%
Cardiac failure
3%
Diarrhoea
3%
Urinary tract infection
3%
Renal failure
2%
Arthralgia
2%
Back pain
2%
Fatigue
2%
Influenza
2%
Blood creatinine increased
2%
Headache
2%
Cough
2%
Anaemia
1%
Angina pectoris
1%
Cardiac failure acute
1%
Blood potassium increased
1%
Acute kidney injury
1%
Pneumonia
1%
Angina unstable
1%
Cardiac failure congestive
1%
Pruritus
1%
Microalbuminuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Individualized Medical Therapy (IMT)
Total
Sacubitril/Valsartan (LCZ696)
Trial Design
1Treatment groups
Experimental Treatment
Group I: sacubitril/valsartanExperimental Treatment1 Intervention
single arm, open label sacubitril/valsartan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sacubitril/valsartan
2016
Completed Phase 3
~13860
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,134 Total Patients Enrolled
68 Trials studying Heart Failure
2,001,496 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had swelling under the skin in the past.You have previously taken part in the PANORAMA-HF study or stopped taking the study drug during PANORAMA-HF Part 2.You have had a bad reaction to the study treatment or similar drugs in the past, or have known reasons that make it unsafe for you to take sacubitril/valsartan.You have kidney-related high blood pressure.You have severe kidney, liver, gastrointestinal, or biliary disorders.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: sacubitril/valsartan
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are middle-aged individuals being accepted into this research project?
"Children aged 1 year to 18 years old are eligible for this clinical trial. In total, there are 25 clinical trials for patients under 18 and 758 for people 65 and older."
Answered by AI
Could I qualify to join this experiment?
"This study, which is looking for 217 individuals with a history of heart failure, has the following requirements for applicants: They must have given informed consent, be taking the study drug at the EOS visit for PANORAMA-HF Part 2, and not have any major safety concerns."
Answered by AI
What is the primary medical condition that sacubitril/valsartan is indicated for?
"sacubitril/valsartan is most often given to patients with left ventricular dysfunction. It can also be used to lower blood pressure in patients that haven't respond well to other treatments and to prevent cardiovascular events."
Answered by AI
Is this the first time that sacubitril/valsartan is being trialed?
"There are currently 39 different ongoing clinical trials for sacubitril/valsartan. Phase 3 trials, which are the most advanced, are being conducted at 8 of those locations. Most of the research is taking place in Montreal, Quebec, but there are 812 sites total."
Answered by AI
What are some known risks associated with sacubitril/valsartan?
"Although it is still in Phase 3, sacubitril/valsartan has shown efficacy in some patients and has been proven to be safe multiple times. Therefore, it received a score of 3."
Answered by AI
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