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Publications

Journal Article Epublish

PubMed: 40060213 DOI: 10.1016/j.cjco.2024.10.010

First-in-Human Abdominal Aortic Aneurysms Trial with Tricaprin (F-HAAAT): Study Design and Protocol.

CJC Open 7(2):221-230

Authors: Takahito Kamba, Masahiro Yanagawa, Kazuo Shimamura, Satoshi Yamaguchi, Kenji Shirakura, Satomi Okamura, Yuki Nishimura, Tomomi Yamada, Yasushi Sakata, Noriyuki Tomiyama, Shigeru Miyagawa, Ken-Ichi Hirano, Nobuhiro Zaima

Affiliations

  • Laboratory of Cardiovascular Disease, Novel, Non-Invasive, and Nutritional Therapeutics (CNT), Department of Triglyceride Science, Graduate School of Medicine, Osaka University, Osaka, Japan. Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
  • Department of Radiology, Osaka University Graduate School of Medicine, Osaka, Japan.
  • Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
  • Tochino Foundation, Osaka, Japan.
  • Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital, Osaka, Japan.
  • Data Coordinating Center, Department of Medical Innovation, Osaka University Hospital, Osaka, Japan.
  • Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
  • Laboratory of Cardiovascular Disease, Novel, Non-Invasive, and Nutritional Therapeutics (CNT), Department of Triglyceride Science, Graduate School of Medicine, Osaka University, Osaka, Japan.
  • The Laboratory of Applied Cell Biology, Faculty of Agriculture, Kindai University, Nara, Japan.
  • Agricultural Technology and Innovation Research Institute, Kindai University, Nara, Japan.

Abstract

Approximately 2%-12% of individuals aged > 65 years worldwide are estimated to have an abdominal aortic aneurysm (AAA), with a mortality rate exceeding 60% in rupture cases. The sole preventive intervention against rupture is timely surgery, which requires substantial medical resources, including postoperative complication management. Although numerous randomized clinical trials have been performed, no oral medication effectively treats AAA. Tricaprin, a medium-chain triglyceride with 3 capric acids, is used in dietary therapy for metabolic and neurological disorders. Our group recently reported that tricaprin, unlike other medium-chain triglycerides, showed reverse remodelliing of AAA in a rat model. Determining whether this basic finding could be translated to clinical practice is important. The irst-in-uman bdominal ortic neurysms trial with ricaprin (F-HAAAT) proposes the first-in-human AAA trial to confirm the safety of tricaprin use in patients with small AAA, exploring novel assessment methods to evaluate treatment efficacy. This single-centre, open-label, single-arm study will include 10 patients (aged 50-85 years) with small AAA (30-45 mm in diameter) receiving daily oral tricaprin (1.5-3.0 g/d) for 52 weeks. Primary endpoints include safety evaluation of tricaprin determined by monitoring all adverse events, particularly major adverse cardiovascular events, AAA-related adverse events, and other unpredictable events. Secondary endpoints include parameters to validate tricaprin efficacy by measuring AAA diameter, volume, and Agatston score, and analyzing computed tomography values of the aortic aneurysmal wall. Outcomes of the trial may provide insights into noninvasive methods for indirectly analyzing AAA pathologic characteristics and revealing aneurysmal reverse remodelliing (jRCTs051240036, Japan Registry of Clinical Trials).

MeSH

Aortic Aneurysm, Safety, Aneurysm, Aged, Drug-Related Side Effects And Adverse Reactions, Therapeutics, Rupture, Triglycerides, Aortic Aneurysm, Abdominal