Loading
Life sciences · Observational Study
ClinicalTrials.gov · October 30, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07907640). This is a study registration, not published results. Lead sponsor: Sunway University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 80 participants (ESTIMATED). Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure. Interventions: DRUG: Savagen (sacubitril/valsartan). Primary outcome measures: Change in NT-proBNP , Baseline (Month 0) to Month 12. Brief summary: This multicentre, prospective, single-arm cohort study will evaluate the real-world effectiveness and safety of Savagen, an NPRA-approved generic sacubitril/valsartan, in Malaysian adults aged 18 to 70 years with heart failure with reduced ejection fraction (HFrEF; LVEF ≤40%, NYHA class II-III). Approximately 80 patients initiating Savagen as part of routine clinical care at hospitals offering a Heart Failure Medication Therapy Adherence Clinic (HFMTAC) will be followed for 12 months. The primary outcome is the change in NT-proBNP from baseline to 12 months. Secondary outcomes include changes in LVEF, renal function (serum creatinine, eGFR), serum potassium, patient-reported health status (KCCQ) and dietary diversity (Dietary Diversity Score), a composite of cardiovascular death or first heart failure hospitalisation, and adverse events, including hypotension, hyperkalaemia, renal impairment and angioedema. The study does not aim to establish equivalence with the reference product; it will generate local real-world evidence on the effectiveness, tolerability, safety and patient-reported outcomes of generic sacubitril/valsartan in routine Malaysian HFrEF care.