Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Change in NT-proBNP	Baseline (Month 0) to Month 12	Change in NT-proBNP from baseline, measured by a quantitative point-of-care assay (e.g., Roche CARDIAC proBNP+) per the manufacturer's instructions. Also measured at Month 6.
Secondary	Change in LVEF	Baseline to Month 12	Change in left ventricular ejection fraction measured by transthoracic echocardiography.
Secondary	Change in serum creatinine	Baseline to Month 12	Change in serum creatinine from baseline.
Secondary	Change in eGFR	Baseline to Month 12	Change in estimated glomerular filtration rate from baseline.
Secondary	Change in serum potassium	Baseline to Month 12	Change in serum potassium from baseline.
Secondary	Change in KCCQ overall summary score	Baseline to Month 6 and Month 12	Change in Kansas City Cardiomyopathy Questionnaire overall summary score (patient-reported health status).
Secondary	Cardiovascular death or first heart failure hospitalisation (composite)	Baseline to Month 12	Proportion of participants experiencing cardiovascular death or first heart failure hospitalisation during the 12-month follow-up, ascertained at study visits and from medical records; time to first event estimated by Kaplan-Meier analysis.
Secondary	Adverse events and serious adverse events	From initiation of Savagen to Month 12	Incidence, severity (mild, moderate, severe) and nature of all AEs and SAEs as defined by ICH-GCP and Malaysian GVP; relationship to study medication assessed by the site investigator.
Secondary	Adverse events of special interest	From initiation of Savagen to Month 12	Incidence of hypotension, hyperkalaemia, renal impairment and angioedema. From initiation of Savagen to Month 12
Secondary	Change in Dietary Diversity Score (DDS)	Baseline to Month 6 and Month 12	Change in dietary diversity, measured as the number of predefined food groups consumed over the questionnaire recall period (FAO individual dietary diversity guidance); higher scores indicate greater diversity. Exploratory.
Secondary	Association between DDS and clinical outcomes	Baseline to Month 12	Association of DDS (continuous, or predefined categories if used) with NT-proBNP, KCCQ, serum creatinine, eGFR, serum potassium and heart failure hospitalisation, using correlation, covariate-adjusted regression and mixed-effects models. Exploratory and hypothesis-generating.
Other	Comparison with MY-HF registry	Baseline	Comparison of baseline characteristics with a de-identified comparator cohort from the Malaysian Heart Failure (MY-HF) registry, subject to regulatory/ethical approval and data access.
Other	Baseline predictors of outcome	Baseline to Month 12	Baseline predictors (e.g., age, sex, baseline NT-proBNP and KCCQ, renal function, serum potassium, comorbidities, background guideline-directed therapy, baseline Savagen dose and baseline DDS) of clinically significant improvement or adverse outcomes, using multivariable regression.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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