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Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting
Phase 4 trial testing LCZ696 (sacubitril/valsartan) in Hearth Failure With Reduced Ejection Fraction (HFrEF) in 302 participants. Completed in 29 November 2017.
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 302 |
| Start date | 8 March 2016 |
| Primary completion | 7 June 2017 |
| Estimated completion | 29 November 2017 |
| Sites | 32 locations across Canada |
Novartis Pharmaceuticals — full company profile →
Adults 18 to 80, any sex, with Hearth Failure With Reduced Ejection Fraction (HFrEF). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 6. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 64.6 | 59.18 – 69.96 |
The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 12. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 62.3 | 56.78 – 67.72 |
The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the percentage of patients on LCZ696 200mg requiring down-titration. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 11.92 | 8.27 – 15.58 |
The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the number of down-titration during the 12 months treatment period. Dow-titration schemes considered for the analysis are 200 mg to 100 mg; 100 mg to 50 mg; and 50 mg to 0 mg (i.e. treatment discontinuation). The down-titration scheme of 50mg to 0 mg was taken in account in this analysis to ensure to reflect all actual changes in dose. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 188 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 44 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 28 |
The impact of LCZ696 on functional exercise capacity was measured by the Six Minute Walk Test at 6 and 12 months. The 6MWT measures the distance an individual is able to walf over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 392.62 | ± 139.3277 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 11.99 | ± 67.5725 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 8.19 | ± 71.3619 |
To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 21.44 | ± 23.1799 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 27.37 | ± 28.5601 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 46.61 | ± 36.9439 |
To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 37.00 | 35.00 – 42.00 |
To describe the adherence to guideline recommended dosing of beta-blockers and MRAs at 6 and 12 months of treatment of LCZ696. Only descriptive analysis done.
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 298 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 272 |
| Group | Value | 95% CI |
|---|---|---|
| LCZ696 (Sacubitril / Valsartan) | 261 |
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | LCZ696 (Sacubitril / Valsa… |
|---|---|---|
| Cardiac failure congestive | Cardiac disorders | — |
| Pneumonia | Infections and infestations | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Ventricular tachycardia | Cardiac disorders | — |
| Death | General disorders | — |
| Gastroenteritis | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Angina pectoris | Cardiac disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Atrial tachycardia | Cardiac disorders | — |
| Bradyarrhythmia | Cardiac disorders | — |
| Cardiac failure acute | Cardiac disorders | — |
| Congestive cardiomyopathy | Cardiac disorders | — |
| Nodal arrhythmia | Cardiac disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Volvulus | Gastrointestinal disorders | — |
| Multiple organ dysfunction syndrome | General disorders | — |
| Sudden death | General disorders | — |
| Cholecystitis chronic | Hepatobiliary disorders | — |
| Bacteraemia | Infections and infestations | — |
| Reaction | System | LCZ696 (Sacubitril / Valsa… |
|---|---|---|
| Dizziness | Nervous system disorders | — |
| Hypotension | Vascular disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Fatigue | General disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
Most-reported serious reactions: Cardiac failure congestive, Pneumonia, Acute myocardial infarction, Cardiac arrest, Cardiac failure, Ventricular tachycardia, Death, Gastroenteritis.
Data from ClinicalTrials.gov NCT02690974 adverse events section.
The primary purpose of the study was to describe the tolerability of treatment with the optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (HFrEF) in Canada. The study was also to describe the overall tolerability, effectiveness and safety of LCZ696 for the management of HFrEF over 12 months of treatment, as well as describe the patterns of LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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