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. 2024 Feb 1;23(1):49.
doi: 10.1186/s12933-024-02135-z.

Characterizing diabetic cardiomyopathy: baseline results from the ARISE-HF trial

James L Januzzi  1   2 , Stefano Del Prato  3 , Julio Rosenstock  4 , Javed Butler  5   6 , Justin Ezekowitz  7 , Nasrien E Ibrahim  8 , Carolyn S P Lam  9 , Thomas Marwick  10   11 , W H Wilson Tang  12 , Yuxi Liu  13 , Reza Mohebi  13 , Alessia Urbinati  14 , Faiez Zannad  15 , Riccardo Perfetti  14
Affiliations

Characterizing diabetic cardiomyopathy: baseline results from the ARISE-HF trial

James L Januzzi et al. Cardiovasc Diabetol. .

Abstract

Background: Diabetic cardiomyopathy (DbCM) is a form of Stage B heart failure (HF) at high risk for progression to overt disease. Using baseline characteristics of study participants from the Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF) Trial we sought to characterize clinical characteristics of individuals with findings consistent with DbCM.

Methods: Among study participants meeting inclusion criteria, clinical characteristics, laboratory testing, imaging, Kansas City Cardiomyopathy Questionnaire (KCCQ), Physical Activity Scale of the Elderly (PASE) and cardiopulmonary exercise testing (CPET) results were tabulated. Cluster phenogroups were identified.

Results: Among 691 study participants (mean age 67.4 years; 50% were female), mean duration of type 2 diabetes mellitus (T2DM) was 14.5 years. The median (Q1, Q3) N-terminal pro-B type natriuretic peptide and high sensitivity cardiac troponin T were 71 (35, 135) ng/L and 9 [6, 12] ng/L. The most common echocardiographic abnormalities were reduced global longitudinal strain in 25.3% and impaired diastolic relaxation in 17.7%. Despite rather well-preserved KCCQ scores the average PASE score was markedly impaired at 155 accompanied by an average maximal oxygen consumption of 15.7 mL/Kg/minute on CPET. In K-means clustering, 4 phenogroups were identified including a higher-risk group with more advanced age, greater elevation of cardiac biomarkers, and more prevalent evidence for diastolic dysfunction and left ventricular hypertrophy.

Conclusions: Baseline data from the ARISE-HF Trial provide clinical characterization of individuals with T2DM and features of stage B HF, and may help clarify the diagnosis of DbCM.

Trial registration: ARISE-HF, NCT04083339.

Keywords: Cardiomyopathy; Diabetes; Heart failure.

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Conflict of interest statement

Dr. Januzzi is a Trustee of the American College of Cardiology, is a Board member of Imbria Pharmaceuticals, has received research support from Abbott, Applied Therapeutics, HeartFlow Inc, Innolife and Roche Diagnostics, consulting income from Abbott, AstraZeneca, Bayer, Beckman, Boehringer-Ingelheim, Janssen, Novartis, Merck, and Roche Diagnostics, and participates in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Bayer, CVRx, Intercept, Pfizer and Takeda; Dr. Del Prato has served as president of EASD/European Foundation for the Study of Diabetes (EFSD) (2020–2022); has received research grants to the institution from AstraZeneca and Boehringer Ingelheim; has served as advisor for Abbott, Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly & Co., EvaPharma, Jiangsu Hengrui Pharmaceuticals Co., Menarini International, Merck Sharpe & Dohme, Novartis Pharmaceutical Co., Novo Nordisk, Sanofi and Sun Pharmaceuticals; and has received fees for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly & Co., Laboratori Guidotti, Merck Sharpe & Dohme and Novo Nordisk. Dr. Rosenstock has served on scientific advisory boards and received honorarium or consulting fees from Applied Therapeutics, Biomea Fusion, Boehringer Ingelheim, Eli Lilly, Endogenex, Hanmi, Novo Nordisk, Oramed, Regor, Sanofi, Scholar Rock, Structure Therapeutics, Terns Pharma and Zealand; and has received grants/research support from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi, Merck, Oramed, Novartis, Novo Nordisk, Pfizer and Sanofi. Dr. Butler is a consultant to Abbott, American Regent, Amgen, Applied Therapeutic, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiac Dimension, Cardior, CVRx, Cytokinetics, Edwards, Element Science, Innolife, Impulse Dynamics, Imbria, Inventiva, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Roche, Sequana, SQ Innovation, and Vifor; Dr. Ezekowitz reports research support for trial leadership or grants from American Regent, Applied Therapeutics, AstraZeneca, Bayer, Cytokinetics, Merck & Co, Novo Nordisk, Otsuka; honoraria for consultancy from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Otsuka; serves as an advisor to US2.ai….Dr. Ibrahim reports consulting income from Cytokinetics and honoraria from Applied Therapeutics; Dr. Tang is a consultant for Sequana Medical, Cardiol Therapeutics Inc, Genomics plc, Zehna Therapeutics, Renovacor, Boston Scientific, WhiteSwell, Kiniksa Pharmaceuticals, Intellia Therapeutics, CardiaTec Biosciences and has received honorarium from Springer, Belvoir Media Group, and American Board of Internal Medicine; Dr. Lam is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has Received research support from NovoNordisk and Roche Diagnostics; has Served as consultant or on the Advisory Board/ Steering Committee/ Executive Committee for Alleviant Medical, Allysta Pharma, AnaCardio AB, Applied Therapeutics, AstraZeneca, Bayer, Biopeutics, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CardioRenal, Cytokinetics, Darma Inc., EchoNous Inc, Eli Lilly, Impulse Dynamics, Intellia Therapeutics, Ionis Pharmaceutical, Janssen Research & Development LLC, Medscape/WebMD Global LLC, Merck, Novartis, Novo Nordisk, Prosciento Inc, Quidel Corporation, Radcliffe Group Ltd., Recardio Inc, ReCor Medical, Roche Diagnostics, Sanofi, Siemens Healthcare Diagnostics and Us2.ai; and serves as co-founder & non-executive director of Us2.ai. Dr. Zannad reports personal fees from 89bio, Applied Therapeutics, Bayer, Betagenon, Biopeutics, Boehringer, BMS, CVRx, Cardior, Cambrian, Cereno pharmaceutical, Cellprothera, CEVA, Merck, Northsea, Novartis, NovoNordisk, Otsuka, Owkin, Salubris, Servier, having stock options at G3Pharmaceutical and equities at Cereno pharmaceutical, Cardiorenal, Eshmoun Clinical research and being the founder of CVCT. Drs. Urbinati and Perfetti are employees of Applied Therapeutics, Inc. the rest of the authors have no disclosures.

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