Entresto (sacubitril/valsartan) / Novartis, ROVI Pharmaceuticals Laboratories, Otsuka - LARVOL DELTA

Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A (clinicaltrials.gov) - P3 | N=324 | Recruiting | Sponsor: Chong Kun Dang Pharmaceutical | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment open • Trial primary completion date • Cardiovascular • Hypertension

Pharmacological prevention in cardio-oncology: from bench-to-bedside. (PubMed, Heart Fail Rev) - "Neurohormonal blockers, including ACE inhibitors, ARBs, and β-blockers, constitute the foundation of prevention, although their efficacy varies: combinations such as ACEi/ARB with βB yield mixed outcomes, whereas carvedilol offers antioxidant benefits beyond β-blockade. Sacubitril/valsartan (ARNI) has demonstrated improvements in global longitudinal strain and LVEF preservation in the SARAH trial, albeit with associated hypotension risks. Aldosterone antagonists show potential, with spironolactone preserving LVEF and diastolic function, though eplerenone has not shown significant effects. Statins present conflicting data; the STOP-CA trial supports atorvastatin for LVEF preservation, while the PREVENT and SPARE-HF trials found no benefit. Emerging evidence suggests sodium-glucose cotransporter-2 inhibitors (SGLT2i), such as dapagliflozin and empagliflozin, as promising agents, with preclinical and early clinical data indicating cardioprotection through metabolic..."

Journal • Review • Cardiovascular • Hypotension • Metabolic Disorders • Oncology • ICOS

Can sacubitril/valsartan enhance sleep quality and reduce daytime dysfunction in HFrEF patients? (PubMed, Sleep Breath) - "SV improves sleep quality, reduces daytime dysfunction, and enhances exercise capacity in HFrEF patients, indicating potential dual therapeutic benefits. Further studies are needed to explore SV's full impact on sleep parameters and quality of life in this high-risk group."

Journal • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Insomnia • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Natriuretic Peptides as Multisystem Regulators: From Clinical Biomarkers to Therapeutic Targets in Cardio-immunology. (PubMed, Cardiovasc Drugs Ther) - "NPs are promising therapeutic targets across cardio-renal-metabolic spectra, but for many strategies, the evidence remains preclinical or early-phase. We propose a translational roadmap emphasizing mechanistic validation, responder phenotyping, and rigorously powered trials to test NP augmentation (and combinations) in HFrEF, obesity-related HFpEF, pulmonary vascular disease, and immune-cardiometabolic syndromes."

Biomarker • Journal • Review • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Genetic Disorders • Heart Failure • Hypertension • Immunology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Pulmonary Arterial Hypertension • Pulmonary Disease • Renal Disease • Respiratory Diseases

Atrial overdrive pacing in drug-refractory postinfarction electrical storm case report. (PubMed, Medicine (Baltimore)) - "AOP demonstrates dual therapeutic efficacy in refractory post-AMI ES: (1) physiological conduction restoration suppressing ectopic triggers and (2) avoidance of ventricular pacing-induced dyssynchrony. Fluoroscopic guidance ensures lead stability, positioning AOP as a hemodynamically favorable intervention in ES management."

Journal • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Hepatology • Hypertension • Liver Failure • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus • Ventricular Tachycardia

NeoRay: [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake (clinicaltrials.gov) - P1/2 | N=71 | Completed | Sponsor: Advanced Accelerator Applications | Active, not recruiting ➔ Completed | N=51 ➔ 71 | Trial completion date: Dec 2026 ➔ Nov 2025 | Trial primary completion date: Nov 2025 ➔ Jan 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Lung Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • CDK4 • HER-2

Improvement in Right Ventricular Function and Pulmonary Pressures in Patients With Severe Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction Treated With Sacubitril-Valsartan. (PubMed, Pulm Circ) - "Diastolic function parameters (E velocity, E/e', LAVI) did not show significant changes. These findings suggest that sacubitril-valsartan could improve pulmonary pressures, RV dimensions, RV-PA coupling, TR severity, and functional status in HFpEF-PH patients, supporting its potential therapeutic role."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Sacubitril/Valsartan Attenuates Inflammation and Fibrosis Associated With Decreased Integrin α8 and Inhibits Hepatocarcinogenesis in a Rat Model of Metabolic Dysfunction-Associated Steatohepatitis. (PubMed, Hepatol Res) - "Sac/Val attenuated fibrosis and inflammation in MASH, potentially through suppression of Itga8 expression, oxidative stress, and inflammasome signaling, highlighting Sac/Val as a promising MASH therapy."

Journal • Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cancer • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Oncology • NLRP3 • TGFB1

Sacubitril/Valsartan vs Enalapril in Heart Failure Due to Chagas Disease: An Open-Label, Multicenter Randomized Clinical Trial. (PubMed, JAMA) - P4 | "In patients with HF with reduced ejection fraction due to Chagas disease, there was no significant difference in clinical outcomes between sacubitril/valsartan and enalapril, but there was a greater reduction in NT-proBNP at 12 weeks in patients in the sacubitril/valsartan group. ClinicalTrials.gov Identifier: NCT04023227."

Clinical • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Sacubitril/Valsartan vs Enalapril in Heart Failure Due to Chagas Disease: Research Summary. (PubMed, JAMA) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Postoperative hemodynamic stability of patients treated with the sacubritil-valsartan combination in cardiac surgery. (PubMed, Anaesth Crit Care Pain Med) - "In this exploratory study in cardiac surgery, preoperative treatment with SVC was not associated with increased vasoplegia and vasoactive drug consumption."

Journal • Acute Coronary Syndrome • Acute Kidney Injury • Cardiovascular • Congestive Heart Failure • Critical care • Heart Failure • Renal Disease

Cognitive Safety and Outcomes of Pharmacological Management in Heart Failure: A Systematic Review. (PubMed, Pharmaceuticals (Basel)) - "In HF populations, sacubitril/valsartan showed no adverse cognitive effects versus other RAAS inhibitors...Comparisons of anticoagulants (dabigatran vs. warfarin; warfarin vs. aspirin) revealed no differences in cognitive trajectories, while optimized medical therapy was associated with parallel improvements in cognitive scores, left ventricular function, and renal parameters...Optimized medical therapy may even support cognitive improvement alongside cardiac and renal recovery. Routine cognitive assessment should be integrated into HF care to support individualized management."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Congestive Heart Failure • Dementia • Heart Failure

Effect of Sacubitril/Valsartan, Ivabradine, and Captopril on Anxiety-like Behavior in Spontaneously Hypertensive Rats. (PubMed, Int J Mol Sci) - "Additionally, correlation analysis indicated that anxiety-like behavior in Wistar rats or SHR, either with or without cardiovascular therapy, was independent of SBP, HR, LVW, or LVHP. The level of anxiety-like behavior can, therefore, be considered part of the inherent neurobehavioral traits unrelated to fundamental hemodynamic or structural cardiovascular parameters."

Journal • Preclinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Mood Disorders • Psychiatry

Results of Two Studies of Pharmacokinetics, Safety, and Bioequivalence of Russian Generic Valsartan / Sacubitril Compared to the Original Valsartan / Sacubitril in Healthy Volunteers. (PubMed, Kardiologiia) - "Both study drugs were well tolerated; all adverse events (AEs) were mild and did not require additional therapy. No clinically significant AEs were observed during the study. The study demonstrated bioequivalence of Akrivario (valsartan + sacubitril) to the reference drug Uperio (valsartan + sacubitril)."

Clinical • Journal • PK/PD data

Conservative Management of Spontaneous Posterior Mediastinal Intercostal Artery Hemorrhage: A Case Report and Literature Review. (PubMed, J Emerg Med) - "Blood pressure was initially controlled with intravenous nicardipine, followed by oral sacubitril/valsartan and nifedipine administration. Conservative management may be feasible in hemodynamically stable patients with natural tamponade; however, careful patient selection and close monitoring are crucial. Awareness of this condition can help avoid unnecessary invasive procedures."

Journal • Back Pain • Cardiovascular • Genetic Disorders • Hematological Disorders • Hypertension • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Mood Disorders • Musculoskeletal Pain • Neurofibromatosis • Pain • Peripheral Arterial Disease • Solid Tumor • Systemic Lupus Erythematosus

SHOT: Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity (clinicaltrials.gov) - P4 | N=104 | Not yet recruiting | Sponsor: Jing Liu

New P4 trial • Cardiovascular • Genetic Disorders • Hypertension • Obesity

Effectiveness of Sacubitril/Valsartan in Reducing Hospitalizations in Older Belgian Adults with Heart Failure and Reduced Ejection Fraction: An Age-Stratified Study. (PubMed, Drugs Aging) - "Broader application of guideline-directed medical therapy in geriatric heart failure with reduced ejection fraction care should be prioritized."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

INITIATE: Initiation of ARNi and SGLT2i in Patients With HFrEF (clinicaltrials.gov) - P4 | N=62 | Completed | Sponsor: Universidade do Porto | Recruiting ➔ Completed | N=172 ➔ 62 | Trial completion date: Feb 2025 ➔ Jul 2025 | Trial primary completion date: Nov 2024 ➔ Jul 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

The Efficacy of Sacubitril/Valsartan in the Treatment of Peripartum Cardiomyopathy: A Retrospective Analysis of Four Cases. (PubMed, Turk Kardiyol Dern Ars) - "The management of PPCM requires a multidisciplinary approach, emphasizing the importance of timely intervention. Our observations indicate that S/V could be considered a possible therapeutic option, but confirmation in larger cohorts is needed."

Journal • Retrospective data • Cardiomyopathy • Cardiovascular

Comparative analysis of adverse events between sacubitril/valsartan and valsartan using the FAERS database: a disproportionality analysis. (PubMed, Expert Opin Drug Saf) - "Unique AEs for valsartan included fear of disease (n = 137, ROR 47.57), thrombotic stroke (n = 31, ROR 25.60), merycism (n = 30, ROR 79.41), and eosinophilic colitis (n = 11, ROR 20.62). Sacubitril/valsartan and valsartan exhibit distinct AE risk profiles in cardiovascular disease treatment, underscoring the need for large-scale clinical trials and mechanistic studies on sacubitril to validate these findings."

Adverse events • Journal • Cardiovascular • Congestive Heart Failure • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hypertension • Immunology • Ischemic stroke • Myocardial Infarction

Quantitative Evaluation of Cardiac Function Improvement by Conventional Cardiology Drug Regimens Combined with Sacubitril/Valsartan Sodium in Heart Failure Patients. (PubMed, Int J Gen Med) - "It achieves this by modulating neuroendocrine function, counteracting adverse effects, and promoting the reversal of ventricular remodeling. The treatment also demonstrates good safety, effectively enhancing patients' exercise capacity and quality of life."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Reply to 'Sacubitril/Valsartan in Heart Failure: A Critical Look at Dementia Risk and Future Study Pathways'. (PubMed, Eur Heart J Cardiovasc Pharmacother) - No abstract available

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Congestive Heart Failure • Dementia • Heart Failure

Effects of sacubitril/valsartan according to daily salt intake and comparison with thiazide add-on treatment in patients with uncontrolled hypertension. (PubMed, Hypertens Res) - "In conclusion, daily salt intake does not influence the antihypertensive effects of sacubitril/valsartan. Furthermore, sacubitril/valsartan demonstrated superior efficacy over thiazides in patients with high salt intake, in addition to superior antihypertensive effects."

Journal • Cardiovascular • Hypertension

Sacubitril-Valsartan for the Prevention of Anthracycline Cardiotoxicity in Patients With Elevated Cardiac Troponin I Concentration During Chemotherapy: A Double-Blind Randomized Placebo-Controlled Clinical Trial: The SARAH Trial. (PubMed, Circulation) - "The SARAH trial (Sacubitril-Valsartan for the Prevention of Anthracycline Cardiotoxicity in Patients With Elevated hs-cTnI Concentrations During Chemotherapy) demonstrated the potential of sacubitril-valsartan therapy to reduce the incidence of left ventricular dysfunction, as assessed by global longitudinal strain, in patients with elevated high-sensitivity cardiac troponin I after anthracycline treatment. URL: https://ensaiosclinicos.gov.br/rg/RBR-5q4gm5b; UTN code: U1111-1274-1961."

Clinical • Journal • Breast Cancer • Cardiovascular • Heart Failure • Hypotension • Oncology • Solid Tumor • TNNI3

Reconsidering Sacubitril/Valsartan Dose Strategies in HFrEF: Evidence and Implications from Real-World Practice-Mini-Review. (PubMed, J Gen Intern Med) - "In a nationwide HFrEF cohort (n = 3953), the adjusted risk of the composite of heart failure hospitalization or all-cause mortality did not differ across average-dose tertiles (highest vs lowest: HR 0.88, 95% CI 0.74-1.06). Conversely, a multicenter cohort (n = 652) showed lower all-cause mortality at 49/51 and 97/103 mg twice daily versus 24/26 mg (24/26 vs 49/51 mg: HR 1.67, 95% CI 1.07-2.59), suggesting that the most consistent gains occur when escalating from very-low to intermediate doses, with heterogeneous incremental benefit beyond that."

Journal • Real-world evidence • Cardiovascular • Congestive Heart Failure • Heart Failure