Studies a generic form of sacubitril/valsartan in adults with heart failure
Follows adults with reduced heart pump strength taking generic sacubitril/valsartan in routine care.
Plain-language title generated from the registry record
Registry title: Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Key facts
- Where
- Kajang and Shah Alam, MalaysiaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07907640, who can take part
Where in Malaysia
- Hospital Sultan Idris Shah SerdangKajang, MalaysiaNo longer taking part
- Hospital Shah AlamShah Alam, MalaysiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunway University
- Trial code
- NCT07907640
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
Real-world Effectiveness and Safety of Savagen in Malaysian Patients With HFrEF: A Prospective Cohort Study
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.
Inclusion: Age 18 to 70 years; Confirmed diagnosis of HFrEF, NYHA functional class II or III; Documented LVEF ≤40% on echocardiogram within the preceding 6 months, with no subsequent measurement showing LVEF >40%; Receiving a stable dose of any one of the following for at least 2 weeks before enrolment: loop diuretic, beta-blocker, mineralocorticoid receptor antagonist (MRA) or SGLT2 inhibitor; Considered eligible for sacubitril/valsartan by the treating physician according to standard clinical practice guidelines.
Exclusion: CRT or ICD implantation within 6 months before enrolment; Previous heart transplant, current LVAD, or planned transplant/LVAD during the study; Concurrent ACE inhibitor, aliskiren or nesiritide; Participation in another investigational drug trial without an adequate washout period, as determined by the investigator; Known hypersensitivity or contraindication to sacubitril or valsartan; Personal or family history of angioedema; Cognitive impairment or any condition that prevents the participant from understanding the study information, completing study procedures, or providing valid informed consent; Active malignancy diagnosed within the past year (except non-melanoma skin cancer); The following may warrant exclusion at the treating physician's clinical discretion: active alcohol or drug abuse; heavy smoking deemed to increase risk; clinically significant asthma, urticaria or severe allergic disorder; blood donation within the past 3 months; HIV, active hepatitis B or C, or positive VDRL (particularly with immunosuppression or hepatic dysfunction); recent or planned major surgery; BMI <18 or >40 kg/m²; Serum potassium >5.2 mEq/L at screening; Pregnant, planning pregnancy, breastfeeding, or woman of childbearing potential not using a highly effective method of contraception.