NCT07907640Not yet recruiting
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Real-world Effectiveness and Safety of Savagen in Malaysian Patients With HFrEF: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 25 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Sunway University
- Diseases
- Heart failure
- NCT number
- NCT07907640
What you commit to
- Study type: Observational
- Planned participants: 80
- From 1 Oct 2026 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Serum potassium \>5.2 mEq/L at screening
Other
- Pregnant, planning pregnancy, breastfeeding, or woman of childbearing potential not using a highly effective method of contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Sultan Idris Shah Serdang Coordinator of this site? Confirm its status | Kajang | Malaysia | Unknown status |
| Hospital Shah Alam Coordinator of this site? Confirm its status | Shah Alam | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.