Cardeva (AlbuBNP) / Teva - LARVOL DELTA

PIONEER-HF: comParIson Of Sacubitril/valsartaN Versus Enalapril on Effect on ntpRo-bnp in Patients Stabilized From an Acute Heart Failure Episode (clinicaltrials.gov) - P4; N=736; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting ➔ Recruiting; Trial primary completion date: Jun 2017 ➔ Apr 2018

Enrollment open • Trial primary completion date • Biosimilar • Cardiovascular • Heart Failure

Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy (clinicaltrials.gov) - P4; N=59; Completed; Sponsor: Tehran University of Medical Sciences

New P4 trial • Biosimilar • Diabetes • Diabetic Nephropathy • Renal Disease

Transforming Growth Factor-β1-mediated cardiac fibrosis: Potential role in HIV and HIV/ART-linked cardiovascular disease. (PubMed) - AIDS - "Supportive clinical data correlate RTV use with elevation of NT-proBNP, a biomarker for CVD. We discuss potential interventions involving intrinsic modulators of inflammation and collagen degradation, including carbon monoxide-based therapeutics."

Biomarker • Journal • Biosimilar • Fibrosis • Gene Therapies • Immunology • Inflammation • Systemic Sclerosis

Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. (PubMed) - "Except for NT-proBNP, no difference was observed for any other end-point. The safety profile of bosentan added to sildenafil was consistent with the known bosentan safety profile.In COMPASS-2, adding bosentan to stable sildenafil therapy was not superior to sildenafil monotherapy in delaying the time to the first morbidity/mortality event."

Journal • Biosimilar

Novel Extracellular Matrix Biomarkers as Predictors of Adverse Outcome in Chronic Heart Failure: Association between Biglycan and Response to Statin therapy in the CORONA trial. (PubMed) - "Although circulating levels of mimecan and biglycan were of limited predictive value in patients with chronic HF, circulating biglycan could be a useful marker for targeting statin therapy in patients with HF."

Journal • Acute Coronary Syndrome • Atherosclerosis • Biosimilar • Dyslipidemia • Heart Failure • Hematological Malignancies • Reperfusion Injury

Significance and Determinants of Cardiac Troponin I in Patients With Obstructive Hypertrophic Cardiomyopathy. (PubMed) - "Serum cTnI is associated with multiple parameters of disease severity, suggesting its great significance in assessing cardiac remodeling in patients with obstructive HC. Left ventricular hypertrophy, as indicated by LVMI, is the major determinant of serum cTnI levels."

Journal • Biosimilar • Myositis

Simple markers can distinguish Takotsubo cardiomyopathy from ST segment elevation myocardial infarction. (PubMed) - Int J Cardiol - "NTproBNP/TnI, NTproBNP/CKMB mass and NTproBNP/EF ratios can distinguish TTC from STEMI at an early stadium. The most accurate marker is the NTproBNP/TnI ratio."

Biomarker • Journal • Acute Coronary Syndrome • Biosimilar

The influence of body composition on the N-terminal pro-B-type natriuretic peptide level and its prognostic performance in patients with acute coronary syndrome: a cohort study. (PubMed) - Cardiovasc Diabetol - "Body mass index and lean mass index, but not percent body fat, are inversely associated with NT-proBNP levels. The prognostic performance of this biomarker may be compromised in patients with high body mass index, percent body fat, or lean mass index. Additionally, the influence of body composition on the NT-proBNP level and its prognostic performance might be attenuated in diabetic patients with ACS."

Biomarker • Journal • Acute Coronary Syndrome • Biosimilar • Diabetes • Obesity

PROTECT: Use of NT-proBNP Testing to Guide Heart Failure Therapy in the Outpatient Setting. (clinicaltrials.gov) - P=N/A; N=300; Active, not recruiting; Sponsor: Massachusetts General Hospital; Phase classification: P3 ➔ P=N/A

Phase classification • Biosimilar • Gene Therapies • Heart Failure

Plasma ADMA associates with all-cause mortality in renal transplant recipients. (PubMed) - "High levels of plasma ADMA are associated with increased mortality in RTR. Our findings connect disturbed NO metabolism with patient survival after kidney transplantation."

Journal • Biosimilar • Graft versus Host Disease • Immunology • Inflammation

Budget Impact Analysis Of N-Terminal Pro-B-Type Natriuretic Peptide Testing For The Diagnosis And Prognosis Of Heart Failure In Greece. (PubMed) - Value Health - No abstract available.

Journal • Biosimilar • Heart Failure

[The prognostic significance of red cell distribution width (RDW) and other red cell parameters in patients with chronic heart failure during two years of observation]. (PubMed) - Kardiol Pol - "Baseline RDW and hemoglobin concentration in patients hospitalized with diagnosis with CHF in NYHA class II-IV seem to be an important predictors of mortality in this population. Among the red blood cell parameters only the RDW proved to be an independent prognostic factor in 1-year follow-up, however, it seems to lose its importance in the long-term follow-up."

Journal • Biosimilar • Gene Therapies • Heart Failure

The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot") (clinicaltrials.gov) - P=N/A; N=67; Terminated; Sponsor: Prof. Dr. Michael Christ; N=460 -> 67 ; Recruiting -> Terminated ; Trial primary completion date: Dec 2015 ->Apr 2015

Enrollment change • Trial primary completion date • Trial termination • Biosimilar • Heart Failure

Impact of B-type natriuretic peptide level on the risk of left atrial appendage thrombus in patients with nonvalvular atrial fibrillation: a prospective study. (PubMed) - Cardiovasc Ultrasound - "BNP is predictive of SEC. However, it does not provide significant incremental value in the prediction of LAA thrombus."

Journal • Biosimilar

B-type natriuretic peptide in predicting the severity of community-acquired pneumonia. (PubMed) - "BNP level is positively correlated with the severity of CAP, and may be used as a biomarker for evaluating the severity of CAP."

Biomarker • Biosimilar • Inflammation

High Serum Immunoglobulin G and M Levels Predict Freedom From Adverse Cardiovascular Events in Hypertension: A Nested Case-Control Substudy of the Anglo-Scandinavian Cardiac Outcomes Trial. (PubMed) - EBioMedicine - "High total serum IgG levels are an independent predictor of freedom from adverse cardiovascular events, particularly those attributed to CHD, in patients with hypertension."

Journal • Acute Coronary Syndrome • Biosimilar • Heart Failure

NT-proBNP and Echocardiographic Parameters for Prediction of Cardiovascular Outcomes in Patients with CKD Stages G2-G4. (PubMed) - Clin J Am Soc Nephrol - "Our data confirm NT-proBNP is an independent predictor of adverse outcomes in patients with CKD. The additional use of echocardiography for improvement of risk stratification is not supported by our results."

Journal • Atherosclerosis • Biosimilar • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Heart Failure

Lipolytic effects of B-type natriuretic peptide (1-32) in adipose tissue of heart failure patients compared with healthy controls (J Am Coll Cardiol) - P=NA, N=23; BNP(1-32) exerts strong lipolytic effects in humans; Despite marked elevation of plasma immunoreactive BNP, the responsiveness of adipose tissue to BNP(1-32) is not attenuated in HF, possibly reflecting a deficiency of endogenous bioactive BNP; Lipolytic effects of BNP can contribute to excessive fatty acid mobilization in advanced HF

Clinical data • Cardiovascular

High B-Type Natriuretic Peptide Hypertensives at Target Blood Pressure: Potential Role of β-Blockers to Reduce Their Elevated Risk. (PubMed) - No abstract available.

Journal • Biosimilar

High-sensitivity cardiac troponin T in geriatric inpatients. (PubMed) - Arch Gerontol Geriatr - "Hs-cTnT elevation caused by non-ischemic acute conditions was very common in geriatric hospitalized patients. Due to increases in baseline hs-cTnT in the elderly, detection of a rise and/or fall in hs-cTnT levels is essential for determining a diagnosis of ACS or AMI in geriatric patients. Further studies are needed to establish age-specific 99th percentile values of hs-cTnT for elderly individuals."

Journal • Acute Coronary Syndrome • Atherosclerosis • Biosimilar • Diabetes • Diabetic Nephropathy • Renal Disease • Reperfusion Injury

Association of restless legs syndrome with oxidative stress and inflammation in patients undergoing hemodialysis. (PubMed) - "This study confirms the high prevalence of RLS among hemodialysis patients and identifies the oxidative stress marker serum 8-OHdG as a significant independent predictor of RLS severity. Further studies are needed to identify detailed risk factors and the pathophysiological role of oxidative stress in RLS."

Journal • Biosimilar • Immunology • Inflammation

The Val142Ile transthyretin cardiac amyloidosis: not only an Afro-American pathogenic variant? A single-centre Italian experience. (PubMed) - "They also showed increased plasma values of NT-proBNP and troponin I. Our data confirm that Caucasian patients with the Val142Ile pathogenic variant have phenotypic manifestations similar to that of African-American one. Moreover, our data clearly show that Val142Ile pathogenic variant is not only an African-American mutation but could be also an underestimated Caucasian variant."

Journal • Biosimilar • Heart Failure • Immunology • Inflammation • Myositis

Hormonal Profile in Patients With Dilated Cardiomyopathy. (PubMed) - "The hormonal levels were low in patients with idiopathic dilated cardiomyopathy. However, the prognostic significance of different hormonal deficiencies was not clear in our study populations who were receiving standard therapies for heart failure and had a relatively stable clinical condition."

Journal • Biosimilar • Heart Failure • Inflammation • Myositis

[Carriage of A Allele of Polymorphic Marker G(-238)A of TNF Gene Is Associated With Unfavorable Prognosis in Patients With Chronic Systolic Heart Failure]. (PubMed) - Kardiologiia - "We obtained data on association between carriage of A allele of polymorphic marker G(-238)A of TNF gene and unfavorable prognosis in patients with CHF and inpraired left ventricular systolic function."

Journal • Biosimilar • Gene Therapies • Heart Failure

Impact of left ventricular diastolic dysfunction on screening for left ventricular systolic dysfunction using b-type natriuretic peptide: A report from the STOP - HF study (ESC 2011) - STOP - HF; P4, N=191; A significant proportion of patients with normal left ventricular systolic function, but elevated b-type natriuretic peptide levels, display evidence of left ventricular diastolic dysfunction as indicated by a Left atrial volume inde >32ml/m2

Clinical data