Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease.

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Rethinking Clinical Trials

JULY 19, 2023

Distinguished Professor of Medicine Professor of Nursing Duke University Neha J. The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. Fortin, M.D.

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Rethinking Clinical Trials

OCTOBER 23, 2024

Another barrier that the research team identified was that existing guidelines from the American College of Cardiology and American Heart Association lack specificity and strong supporting evidence. Patients set their own step count goals according to their baseline when the trial started.

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Velocity Clinical Research

NOVEMBER 21, 2023

“Without clinical research, there would be little if any development of new medicines,” says Isabelle Schenkenberger, MD. I’m proud and excited to be a part of it.” Dr. Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market.

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Scienmag

AUGUST 16, 2020

The […].

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STAT News

AUGUST 3, 2022

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales.

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Rethinking Clinical Trials

APRIL 13, 2023

Nudges and other behavioral interventions are prevalent in industries like business and entertainment, but there is an opportunity for nudges in medicine and health care delivery. Launched in 2016, the Penn Medicine Nudge Unit is the world’s first behavioral design team embedded within a health system.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The trial took place at 64 sites, and randomized 863 patients. Learn more Read about the PROACT Xa study.

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Scienmag

AUGUST 31, 2020

EXPLORER-HCM trial presented in a Hot Line Session today at ESC Congress 2020 Sophia Antipolis, France – 29 Aug 2020: Mavacamten improves heart function and symptoms in patients with obstructive hypertrophic cardiomyopathy, according to results of the EXPLORER-HCM trial presented in a Hot Line session today at ESC Congress 2020.1 “The results (..)

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Scienmag

OCTOBER 15, 2020

Randomized trial studies device designed to reduce embolic events in patients undergoing TAVR NEW YORK – October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of a device designed to reduce cerebral embolization and ischemic stroke, complications of transcatheter aortic valve replacement (TAVR), (..)

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pharmaphorum

FEBRUARY 25, 2022

. “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure,” says Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research.

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Scienmag

NOVEMBER 20, 2020

AHA, ACC issue updated guidance for the evaluation and management of people with HCM The American Heart Association and the American College of Cardiology today released an updated guideline for managing patients with hypertrophic cardiomyopathy (HCM).

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Scienmag

NOVEMBER 16, 2020

SCORED trial of patients with diabetes and chronic kidney disease is first trial of an SGLT2 inhibitor to show benefit across the full range of albuminuria; SOLOIST shows an SGLT2 inhibitor is safe to start in patients hospitalized with heart failure Boston, MA — Less than a decade ago, the Food and Drug Administration approved […].

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The Pharma Data

AUGUST 30, 2021

Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 2 and published in The New England Journal of Medicine 1. 1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.

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XTalks

DECEMBER 19, 2024

Results from the trial of 418 patients showed that subcutaneous Rybrevant reduced the risk of death by 38 percent compared to intravenous Rybrevant. The company is projecting a 2025 to 2030 enterprise sales compound annual growth rate (CAGR) of five to seven percent, driven by J&J Innovative Medicine and J&J MedTech growth.

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The Pharma Data

MAY 31, 2022

the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of AG, announced?the The purpose of the?Ph1 preliminary?efficacy?of F.C.A.H.S. (PI)

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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The Pharma Data

NOVEMBER 12, 2020

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). About the Company: PQ Bypass, Inc.

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The Pharma Data

AUGUST 30, 2021

Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments.

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The Pharma Data

AUGUST 22, 2021

Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). The IDMC recommended that the trial be discontinued due to lack of efficacy. Data from the trial will be provided to inform ongoing research. CHAMPION-ALS.

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XTalks

NOVEMBER 26, 2024

The trial demonstrated a 42 percent reduction in combined cardiovascular death and recurrent hospitalizations at Month 30, with cardiovascular-related hospitalizations reduced by half. A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025.

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Velocity Clinical Research

MARCH 7, 2024

It’s easy to hear the enthusiasm for clinical trials when William Cromwell, MD, FAHA, FNLA , Principal Investigator and a leader of the Velocity Cardiometabolic CARE Council , discusses their importance to patients yesterday, today, and tomorrow. You can also do that by researching, publishing and teaching.

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pharmaphorum

OCTOBER 2, 2020

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. The webinar will also cover: What the NPRCs’ franchise model means for research delivery.

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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Scienmag

MARCH 10, 2021

Using an investigational cell therapy, Medical University of South Carolina pediatricians successfully treated two patients with multisystem inflammatory syndrome in children, a rare but life-threatening complication of COVID-19.

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FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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pharmaphorum

OCTOBER 8, 2020

UK-based RHYTHM AI is to go ahead with a larger clinical trial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication. The post RHYTHM AI cleared for large trial of atrial fibrillation mapping tool appeared first on. months follow up.

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Scienmag

OCTOBER 19, 2020

Randomized clinical trial finds no mortality risk or benefit associated with drug-coated devices in the treatment of peripheral artery disease NEW YORK – October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)

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pharmaphorum

JUNE 1, 2021

The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year. An interim look at the results is due later this month.

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Scienmag

NOVEMBER 13, 2020

Empagliflozin, a recently developed diabetes drug, can effectively treat and reverse heart failure in both diabetic and non-diabetic patients, according to researchers at the Icahn School of Medicine at Mount Sinai.

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Medical Xpress

APRIL 17, 2023

Experiments at 48 elderly care facilities in China find that salt substitutes lowered diastolic blood pressure and resulted in fewer cardiovascular events, according to a paper titled "Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities: a cluster-randomized trial," published in Nature Medicine.

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Scienmag

MARCH 10, 2021

Credit: AlphaMed Press Durham, NC – Results of a clinical trial released in STEM CELLS Translational Medicine provide evidence that treating patients with an injection of bone marrow cells may lead to a reduction in brain injury after a stroke. The study was conducted by Muhammad E. Haque, Ph.D., Savitz, M.D.,

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XTalks

SEPTEMBER 9, 2024

This blog provides a comprehensive look at the medical device giants, ranked by market capitalization , leading the charge into the future of medicine. Billion Boston Scientific continues to shape the future of medical technology with innovations across cardiology, neuromodulation and interventional procedures.

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The Pharma Data

MARCH 22, 2022

New data, including two late-breaking clinical trial presentations on mavacamten and a new analysis of the GUARD-AF study, reinforce the company’s continued commitment to those living with cardiovascular disease. PRINCETON, N.J.–(BUSINESS 22), taking place in Washington, DC, and virtually, from April 2-4, 2022.

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Scienmag

OCTOBER 30, 2020

That is the conclusion of a study published in the October 2020 issue of Academic Emergency Medicine (AEM), […]. Credit: KIRSTY CHALLEN, B.SC., MBCHB, MRES, PH.D.,

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

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