Heart Failure Society of America

Sleep Number Unveils New Research Linking Sleep Abnormalities with Risk of Heart Failure

Retrieved on: 
Tuesday, October 17, 2023
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The study, titled "Sleep Abnormalities Among Community Participants at Risk for Heart Failure," leveraged longitudinal sleep data from Sleep Number smart beds with Mayo Clinic’s AI capabilities and clinical expertise.

Key Points: 
  • The study, titled "Sleep Abnormalities Among Community Participants at Risk for Heart Failure," leveraged longitudinal sleep data from Sleep Number smart beds with Mayo Clinic’s AI capabilities and clinical expertise.
  • View the full release here: https://www.businesswire.com/news/home/20231016764432/en/
    Today, Sleep Number Corporation announced new research presented at the Heart Failure Society of America Annual Scientific Meeting in Cleveland.
  • Data presented show results of a study in collaboration with investigators at Mayo Clinic analyzing the connection between sleep abnormalities and heart failure with preserved ejection fraction (HFpEF), the most common cause of heart failure.
  • “By connecting sleep disturbances and HFpEF risk, this study could suggest that addressing sleep issues may potentially play a role in preventing or managing heart failure,” said Raj Mills, Vice President, SleepIQ Health and Research, Sleep Number.

Alnylam Announces Receipt of Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis

Retrieved on: 
Monday, October 9, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, ATTR, Symantec Endpoint Protection, Cardiomyopathy, Premedication, Food, IRR, OLE, Heart Failure Society of America, Shanda, Nyctalopia, TTR, Risk, Therapy, State, Amyloidosis, RNA interference, Vitamin A deficiency, Abdominal pain, Patisiran, Nausea, Headache, Polyneuropathy, Health status of Asian Americans, Paracetamol, Vitamin A, Periodic breathing, Month, CRL, ALN, ASM, Back pain, Patient, Bachelor of Medicine, Bachelor of Surgery, Medication, New Drug Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RDA, Alnylam Pharmaceuticals, APOLLO, EAP, Serum, Quality of life, Pharmaceutical industry, Medical device, Medical imaging, Dietary supplement

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company’s supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.

Key Points: 
  • Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company’s supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.
  • Patisiran is the established name for ONPATTRO®, which is approved by the FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
  • The CRL did not identify any issues with respect to clinical safety, study conduct, drug quality or manufacturing.
  • As a result of the CRL, the Company will no longer pursue an expanded indication for patisiran in the U.S.

WhiteSwell Announces Successful Treatment of Acute Decompensated Heart Failure Patients in its Early Feasibility DELTA-HF Study

Retrieved on: 
Saturday, October 7, 2023
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WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive initial results from its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.

Key Points: 
  • WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive initial results from its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System.
  • The data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio.
  • Nine hospitalized patients received eLym therapy in conjunction with diuretic therapy, while six patients received standard of care treatment with loop diuretics alone.
  • “It cannot be overemphasized how significant and challenging it is to fully decongest patients hospitalized with decompensated heart failure.

Alnylam to Present Additional Data for Patisiran in Patients With the Cardiomyopathy of ATTR Amyloidosis, Including 24-Month Results From the APOLLO-B Phase 3 Study, at the Heart Failure Society of America Annual Scientific Meeting 2023

Retrieved on: 
Friday, October 6, 2023
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Data from an interim analysis of the ongoing open-label extension (OLE) period of the APOLLO-B Phase 3 study of patisiran in patients with the cardiomyopathy of ATTR amyloidosis through 24 months will be presented.

Key Points: 
  • Data from an interim analysis of the ongoing open-label extension (OLE) period of the APOLLO-B Phase 3 study of patisiran in patients with the cardiomyopathy of ATTR amyloidosis through 24 months will be presented.
  • Patisiran is the established name for ONPATTRO®, which is approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
  • In a controlled clinical study, 19% of ONPATTRO-treated patients experienced IRRs, compared to 9% of placebo-treated patients.
  • Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness).

Late-Breaking Data Confirms Safety of Axon Therapies' Innovative Heart Failure Procedure and Identifies Patients Most Likely to Benefit from SAVM Therapy

Retrieved on: 
Sunday, October 8, 2023
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"SAVM utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients.

Key Points: 
  • "SAVM utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients.
  • The full treatment arm results confirmed the SAVM procedure was safe with no difference in procedure-related adverse events compared to the sham arm.
  • The improvements SAVM demonstrated in the responder group at 6 months were sustained in patients who have available 12-month data.
  • These data will be foundational to our efforts to bring this therapy to the patients who need it most."

Heart Failure (HF) Rate Expected to Rise to 8.5 Million Americans by 2030. New HFSA Initiative Identifies Rapidly Changing Landscape of HF in the U.S.

Retrieved on: 
Tuesday, October 3, 2023
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ROCKVILLE, Md., October 3, 2023 /PRNewswire/ -- HF StatsSM, a new initiative by the Heart Failure Society of America (HFSA) , revealed that one in four individuals are projected to develop heart failure (HF) in their lifetime.

Key Points: 
  • ROCKVILLE, Md., October 3, 2023 /PRNewswire/ -- HF StatsSM, a new initiative by the Heart Failure Society of America (HFSA) , revealed that one in four individuals are projected to develop heart failure (HF) in their lifetime.
  • HF StatsSM presents the latest data on the epidemiology, differences, and outcomes according to sex, race, ethnicity, and age.
  • The HF StatsSM Initiative seeks to fill this gap by providing essential heart failure data to clinicians, researchers, policymakers, and patients living with HF.
  • Approximately 6.7 million Americans over 20 years of age have heart failure (HF), and the prevalence is expected to rise to 8.5 million Americans by 2030.

Cytokinetics Announces Upcoming Presentations at the 2023 HCMS Scientific Sessions and the HFSA Annual Scientific Meeting

Retrieved on: 
Monday, October 2, 2023
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SOUTH SAN FRANCISCO, Calif., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK), today announced upcoming presentations at the 2023 Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions on October 6, 2023, and at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place from October 6-9, 2023, both taking place in Cleveland, OH.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK), today announced upcoming presentations at the 2023 Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions on October 6, 2023, and at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place from October 6-9, 2023, both taking place in Cleveland, OH.
  • Title: Baseline Characteristics of Patients in SEQUOIA-HCM: A Phase 3 Trial of Aficamten in Obstructive Hypertrophic Cardiomyopathy
    Title: Cardiovascular Hospitalizations Post Septal Myectomy for Obstructive Hypertrophic Cardiomyopathy: A 3-year Analysis of 5,101 Patients

Lexicon to Present Post Hoc Analysis of Scored Clinical Trial at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023

Retrieved on: 
Thursday, September 28, 2023
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THE WOODLANDS, Texas, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a new analysis of clinical trial data for INPEFA® (sotagliflozin) will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, October 6-9, 2023 in Cleveland, Ohio.

Key Points: 
  • SCORED was one of two randomized, double-blind, placebo-controlled Phase 3 cardiovascular outcomes studies that led to FDA approval
    THE WOODLANDS, Texas, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a new analysis of clinical trial data for INPEFA® (sotagliflozin) will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, October 6-9, 2023 in Cleveland, Ohio.
  • Details of the presentation are as follows:
    Sotagliflozin Reduces The Risk Of Cardiovascular Events In Patients With Left Ventricular Hypertrophy Without Hypertension: A Post Hoc Analysis From SCORED – an ePoster presentation, Sunday, October 8, 8:00 - 8:30 a.m.
  • ET, Viewing Session VI, Huntington Convention Center, presented by Michael J. Davies, PhD, executive director of clinical development, Lexicon Pharmaceuticals.
  • On May 26, 2023, the U.S. Food and Drug Administration approved INPEFA, a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

Tenaya Therapeutics to Present Data for TN-301 and TN-201 at Upcoming Medical Conferences

Retrieved on: 
Thursday, September 21, 2023
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SOUTH SAN FRANCISCO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced today that poster presentations related to its TN-201 and TN-301 programs will be presented at the 2023 Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions taking place October 6, 2023, and at the Heart Failure Society of America (HFSA) Annual Scientific Meeting occurring October 6-9, 2023. Both meetings are being held this year in Cleveland, Ohio.

Key Points: 
  • TN-301 is Tenaya’s proprietary, highly selective small molecule inhibitor of histone deacetylase 6 (HDAC6) being developed for the potential treatment of heart failure with preserved ejection fraction (HFpEF).
  • Data to be presented at HFSA will include results from the company’s Phase 1 clinical trial of TN-301 in healthy adult participants.
  • Tenaya has previously reported that TN-301 was generally well tolerated and that target engagement was achieved.
  • The company will also present new data from preclinical studies examining the effects of its HDAC6 inhibitor in combination with an approved HFpEF treatment in a model of disease.

Cardiovascular Organizations Pursue New, Independent Medical Board

Retrieved on: 
Thursday, September 21, 2023
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WASHINGTON, Sept. 21, 2023 /PRNewswire/ -- Many of the nation's most prominent cardiovascular organizations, representing tens of thousands of physicians, unite today to pursue the creation of a new Board for cardiovascular medicine. The proposed new Board would be independent of the American Board of Internal Medicine, where the cardiology certification process currently exists. Collectively, the American College of Cardiology (ACC), Heart Failure Society of America (HFSA), Heart Rhythm Society (HRS) and Society for Cardiovascular Angiography & Interventions (SCAI) are working together to submit a new Board application, with potential for additional consortium members to join.

Key Points: 
  • WASHINGTON, Sept. 21, 2023 /PRNewswire/ -- Many of the nation's most prominent cardiovascular organizations, representing tens of thousands of physicians, unite today to pursue the creation of a new Board for cardiovascular medicine.
  • The proposed new Board would be independent of the American Board of Internal Medicine, where the cardiology certification process currently exists.
  • "We know that the cardiovascular community is ready for an independent, self-governed entity, and we are proud to develop this new Board with cardiologists and cardiology organizations at the helm."
  • Together, the consortium will submit an application to the American Board of Medical Specialties (ABMS), requesting an independent medical Board for cardiovascular medicine to pursue a new competency-based approach to continuous certification—one that harnesses the knowledge, skills and attitudes required to sustain professional excellence and care for cardiovascular patients effectively.