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74 results on '"Honarpour, Narimon"'

51. Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency

Author

Anker, Stefan D., Schroeder, Stefan, Atar, Dan, Bax, Jeroen J., Ceconi, Claudio, Cowie, Martin R., Crisp, Adam, Dominjon, Fabienne, Ford, Ian, Ghofrani, Hossein-Ardeschir, Gropper, Savion, Hindricks, Gerhard, Hlatky, Mark A., Holcomb, Richard, Honarpour, Narimon, Jukema, J. Wouter, Kim, Albert M., Kunz, Michael, Lefkowitz, Martin, Le Floch, Chantal, Landmesser, Ulf, McDonagh, Theresa A., McMurray, John J., Merkely, Bela, Packer, Milton, Prasad, Krishna, Revkin, James, Rosano, Giuseppe M.C., Somaratne, Ransi, Stough, Wendy Gattis, Voors, Adriaan A., Ruschitzka, Frank, and Imperial College Trust

Subjects
Heart Failure, Surrogate endpoints, Clinical Trials as Topic, Endpoint determination, Socio-culturale, 1102 Cardiovascular Medicine And Haematology, Clinical trial, Hospitalization, Treatment Outcome, Cardiovascular System & Hematology, Heart failure, Cardiology and Cardiovascular Medicine, Cause of Death, Activities of Daily Living, Outcome Assessment, Health Care, Quality of Life, Humans, Mortality
Abstract

Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and have adequate power to draw conclusions about the efficacy and safety of new treatments for heart failure. Additionally, the societal and health system perspectives on heart failure have raised interest in ascertaining the effects of therapy on outcomes such as repeat hospitalization and the patient’s burden of disease. Thus, novel methods for using composite endpoints in clinical trials (e.g. clinical status composite endpoints, recurrent event analyses) are being applied in current and planned trials. Endpoints that measure functional status or reflect the patient experience are important but used cautiously because heart failure treatments may improve function yet have adverse effects on mortality. This paper discusses the use of traditional and new composite endpoints, identifies qualities of robust composites, and outlines opportunities for future research. peerReviewed

Published
2015

55. PCSK9 inhibition-mediated reduction in Lp(a) with evolocumab: an analysis of 10 clinical trials and the LDL receptor's role

Author

Raal, Frederick J., primary, Giugliano, Robert P., additional, Sabatine, Marc S., additional, Koren, Michael J., additional, Blom, Dirk, additional, Seidah, Nabil G., additional, Honarpour, Narimon, additional, Lira, Armando, additional, Xue, Allen, additional, Chiruvolu, Padmaja, additional, Jackson, Simon, additional, Di, Mei, additional, Peach, Matthew, additional, Somaratne, Ransi, additional, Wasserman, Scott M., additional, Scott, Rob, additional, and Stein, Evan A., additional

Published
2016
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56. Erratum to “Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency” [Eur J Heart Fail 2016;18:482‐489]

Author

Anker, Stefan D., primary, Schroeder, Stefan, additional, Atar, Dan, additional, Bax, Jeroen J., additional, Ceconi, Claudio, additional, Cowie, Martin R., additional, Crisp, Adam, additional, Dominjon, Fabienne, additional, Ford, Ian, additional, Ghofrani, Hossein‐Ardeschir, additional, Gropper, Savion, additional, Hindricks, Gerhard, additional, Hlatky, Mark A., additional, Holcomb, Richard, additional, Honarpour, Narimon, additional, Jukema, J. Wouter, additional, Kim, Albert M., additional, Kunz, Michael, additional, Lefkowitz, Martin, additional, Floch, Chantal Le, additional, Landmesser, Ulf, additional, McDonagh, Theresa A., additional, McMurray, John J., additional, Merkely, Bela, additional, Packer, Milton, additional, Prasad, Krishna, additional, Revkin, James, additional, Rosano, Giuseppe M.C., additional, Somaratne, Ransi, additional, Stough, Wendy Gattis, additional, Voors, Adriaan A., additional, and Ruschitzka, Frank, additional

Published
2016
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57. REDUCTION IN LIPOPROTEIN (A) WITH EVOLOCUMAB: ELUCIDATION OF THE ROLE OF THE LDL RECEPTOR FROM CLINICAL TRIALS AND IN-VITRO MODELS

Author

Raal, Frederick J., primary, Giugliano, Robert P., additional, Sabatine, Marc, additional, Koren, Michael, additional, Blom, Dirk, additional, Seidah, Nabil G., additional, Honarpour, Narimon, additional, Pineda, Armando Lira, additional, Xue, Allen, additional, Jackson, Simon, additional, Di, Mei, additional, Peach, Matthew, additional, Somaratne, Ransi, additional, Wasserman, Scott, additional, Scott, Robert, additional, and Stein, Evan, additional

Published
2016
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61. Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial

Author

Giugliano, Robert P., Mach, Francois, Zavitz, Kenton, Kurtz, Christopher, Schneider, Jingjing, Wang, Huei, Keech, Anthony, Pedersen, Terje R., Sabatine, Marc S., Sever, Peter S., Honarpour, Narimon, Wasserman, Scott M., and Ott, Brian R.

Published
2017
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62. Effects of Long-Term, Monthly Administration of the PCSK9 Inhibitor Evolocumab in Patients with Dysglycemia or Metabolic Syndrome

Author

Henry, Robert R., primary, Holman, Rury R., additional, Giugliano, Robert P., additional, Raal, Frederick J., additional, Sullivan, David, additional, Honarpour, Narimon, additional, Nelson, Patric, additional, Elliott, Mary, additional, LIU, Thomas, additional, Wasserman, Scott M., additional, and Koren, Michael J., additional

Published
2014
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71. Abstract 13871: Evolocumab and Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: Analysis From FOURIER

Author

Gencer, Baris, Mach, Fran?ois, Murphy, Sabina A, De Ferrari, Gaetano M, Huber, Kurt, Lewis, Basil S, Ferreira, Jorge, Kurtz, Christopher E, Wang, Huei, Honarpour, Narimon, Keech, Anthony C, Sever, Peter S, Pedersen, Terje R, Sabatine, Marc S, and Giugliano, Robert P

Abstract

Background:The 2018 Cholesterol Guideline identified pts with recent MI (within 12 months) as very-high risk and for whom it is reasonable to add a PCSK9 inhibitor antibody to maximal statin if LDL-C ?70 mg/dL. We report the clinical efficacy of evolocumab in pts with recent MI in FOURIER.Methods:FOURIER randomized 27,564 pts with stable ASCVD treated with statin to evolocumab vs placebo followed for 2.2 years median. In this analysis pts with known date of prior MI (n=22,320) were stratified as recent MI (between 1-12 months) vs remote MI (>12 months prior to randomization). We assessed the efficacy of evolocumab on the primary endpoint (PEP: CV death, MI, stroke, UA, or coronary revascularization) and the key secondary EP (SEP: CV death, MI or stroke) in these subgroups.Results:The 5711 pts with a recent MI were more likely to be younger and treated with high-intensity statin (77.3 % vs. 69.3 %) and less likely to have a history of stroke, PAD, CABG, hypertension, metabolic syndrome, renal dysfunction, diabetes compared with the 16,609 pts with a remote MI. In pts with a recent MI, evolocumab reduced the risk of the PEP & key SEP by 19% (HR 0.81, 95% CI 0.70-0.93) and 25% (HR 0.75, 0.62-0.91), respectively. In contrast, in pts with a remote MI, the respective relative risk reductions were 8% (HR 0.92, 0.84-1.01) and 15% (HR 0.85, 0.76-0.96) (P-int 0.13 & 0.24). Given the higher event rate in pts with a recent MI, the absolute risk reductions over 3 years with evolocumab for the PEP and key SEP tended to be greater: 3.7% and 3.2%, respectively, vs. 1.1% and 1.3% (Figure).Conclusion:Patients with a recent MI (between 1-12 months) were at higher risk for CV events and tended to experience greater relative and absolute risk reductions with evolocumab than those with more remote MIs. These findings support guideline recommendations to lower LDL-C intensively after a recent MI.

Published
2019
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72. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial

Author

Macdonald, Peter, Cleland, John G F, Honarpour, Narimon, Metra, Marco, McMurray, John J V, Ezekowitz, Justin A, Ponikowski, Piotr, Johnston, James, Felker, G Michael, Adams, Kirkwood F, Tomcsányi, János, Serpytis, Pranas, Voors, Adriaan A, Monsalvo, Maria Laura, Malik, Fady I, Spinar, Jindrich, Goudev, Assen, Teerlink, John R, Solomon, Scott D, Vandekerckhove, Hans J, and Mitrovic, Veselin

Subjects
3. Good health
Abstract

BACKGROUND: Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil. METHODS: In this randomised, double-blind study, done at 87 sites in 13 countries, we recruited patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction 40% or lower. Patients were randomly assigned equally, via an interactive web response system, to receive 25 mg oral omecamtiv mecarbil twice daily (fixed-dose group), 25 mg twice daily titrated to 50 mg twice daily guided by pharmacokinetics (pharmacokinetic-titration group), or placebo for 20 weeks. We assessed the maximum concentration of omecamtiv mecarbil in plasma (primary endpoint) and changes in cardiac function and ventricular diameters. This trial is registered with ClinicalTrials.gov, number NCT01786512. FINDINGS: From March 17, 2014, to March 5, 2015, we enrolled 150 patients in the fixed-dose omecamtiv mecarbil group and 149 in the pharmacokinetic-titration and placebo groups. Mean maximum concentration of omecamtiv mecarbil at 12 weeks was 200 (SD 71) ng/mL in the fixed-dose group and 318 (129) ng/mL in the pharmacokinetic-titration group. For the pharmacokinetic-titration group versus placebo group at 20 weeks, least square mean differences were as follows: systolic ejection time 25 ms (95% CI 18-32, p

74. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial.

Author

COSMIC-HF Investigators, Teerlink, John R., Goudev, Assen, Macdonald, Peter, Metra, Marco, Mitrovic, Veselin, Ponikowski, Piotr, Serpytis, Pranas, Spinar, Jindrich, Tomcsányi, János, Vandekerckhove, Hans J., Voors, Adriaan A., Monsalvo, Maria Laura, Johnston, James, Honarpour, Narimon, Malik, Fady I., Adams, Kirkwood F Jr, Felker, G. Michael, McMurray, John J. V., and Solomon, Scott D.

Subjects
*MYOSIN, *CARDIAC contraction, *CONTRACTILITY (Biology), *HEART failure, *PHARMACOKINETICS, *RANDOMIZED controlled trials, *PHYSIOLOGY, *MUSCLE protein metabolism, *COMPARATIVE studies, *DOSE-effect relationship in pharmacology, *LEFT heart ventricle, *HEART physiology, *RESEARCH methodology, *MEDICAL cooperation, *MUSCLE proteins, *ORAL drug administration, *PEPTIDE hormones, *PEPTIDES, *RESEARCH, *STATISTICAL sampling, *UREA, *EVALUATION research, *VENTRICULAR remodeling, *STROKE volume (Cardiac output)
Abstract

Background: Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil.Methods: In this randomised, double-blind study, done at 87 sites in 13 countries, we recruited patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction 40% or lower. Patients were randomly assigned equally, via an interactive web response system, to receive 25 mg oral omecamtiv mecarbil twice daily (fixed-dose group), 25 mg twice daily titrated to 50 mg twice daily guided by pharmacokinetics (pharmacokinetic-titration group), or placebo for 20 weeks. We assessed the maximum concentration of omecamtiv mecarbil in plasma (primary endpoint) and changes in cardiac function and ventricular diameters. This trial is registered with ClinicalTrials.gov, number NCT01786512.Findings: From March 17, 2014, to March 5, 2015, we enrolled 150 patients in the fixed-dose omecamtiv mecarbil group and 149 in the pharmacokinetic-titration and placebo groups. Mean maximum concentration of omecamtiv mecarbil at 12 weeks was 200 (SD 71) ng/mL in the fixed-dose group and 318 (129) ng/mL in the pharmacokinetic-titration group. For the pharmacokinetic-titration group versus placebo group at 20 weeks, least square mean differences were as follows: systolic ejection time 25 ms (95% CI 18-32, p<0·0001), stroke volume 3·6 mL (0·5-6·7, p=0·0217), left ventricular end-systolic diameter -1·8 mm (-2·9 to -0·6, p=0·0027), left ventricular end-diastolic diameter -1·3 mm, (-2·3 to 0·3, p=0·0128), heart rate -3·0 beats per min (-5·1 to -0·8, p=0·0070), and N-terminal pro B-type natriuretic peptide concentration in plasma -970 pg/mL (-1672 to -268, p=0·0069). The frequency of adverse clinical events did not differ between groups.Interpretation: Omecamtiv mecarbil dosing guided by pharmacokinetics achieved plasma concentrations associated with improved cardiac function and decreased ventricular diameter.Funding: Amgen. [ABSTRACT FROM AUTHOR]

Published
2016
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