Heart Failure Complicated by Diabetes and Hypertriglyceridemia Heart failure, dyslipidemia, proteome
Conditions
Interventions
Patients assigned to the pemafibrate group will receive pemafibrate a 0.1 mg tablet orally twice a day, in addition to lifestyle guidance including diet and exercise provided by the attending physici
Sponsors
Takeshi Kitai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women who are 18 years of age or older at the time of obtaining consent 2) Patients diagnosed with type 2 diabetes 3) Patients who show fasting TG greater than or equal 150 mg/dL or TG greater than or equal 175 mg/dL at any time within 52 weeks prior to obtaining consent 4) Patients who have been diagnosed with chronic heart failure and have met the following at any point in the past BNP greater than or equal 35 pg/mL or NT-proBNP greater than or equal 125 pg/mL And also Left ventricular ejection fraction (LVEF) <60% 5) Patients who provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who have taken fibrates or pemafibrate within 52 weeks prior to obtaining consent 2. Patients who have changed the dosage (including start and discontinuation) of drugs for heart failure, dyslipidemia, hypertension, and diabetes within 12 weeks prior to obtaining consent. 3. Patients who meet TG greater than 500 mg/dL at the time of obtaining consent 4. Patients with hepatic impairment If you have acute or chronic active viral hepatitis B or C If you are diagnosed with cirrhosis of the liver If you have other serious liver damage 5. Severe renal impairment Patients on dialysis or patients with an eGFR of less than 30 mL/min/1.73 m2 6. Uncontrolled hypertension even under oral antihypertensive medication (systolic blood pressure greater than or equal 160 mmHg or diastolic blood pressure greater than or equal110 mmHg) 7. Type 2 diabetes mellitus with poor glycemic control (HbA1c greater than or equal 9.0% at the time of consent) 8. Heart failure of New York Heart Association(NYHA) cardiac function classification Class IV 9. Patients currently under follow-up with cholelithiasis 10. Patients with a history of acute coronary syndrome, myocarditis, or takotsubo-type cardiomyopathy within 24 weeks prior to obtaining consent 11. Patients who have undergone or are scheduled to receive the following treatments within 24 weeks prior to obtaining consent Pacemaker implantation Cardiac resynchronization therapy Cardiac surgery (including transcatheter cardiac surgery) Ablation treatment for atrial fibrillation, atrial flutter, and atrial tachycardia 12. Patients who have undergone or are scheduled to undergo coronary angioplasty within 12 weeks prior to obtaining consent 13. Patients with a history of hypersensitivity to pemafibrate 14. Patients receiving cyclosporine and rifampicin 15. Pregnant women, lactating women, or men and women who are unable to consent to contraception during the trial 16. Patients who have already participated in other clinical trials or plan to participate during the study period 17. Patients who are judged by the Principal Investigator or Co-Investigator to be inappropriate for participation in the Study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in flush rate of 123I-beta-methyl-P-iodophenyl-pentadecanoic acid(BMIPP) myocardial scintigram Single Photon Emission Computed Tomography(SPECT) from the baseline to week 24 after the start of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Percent change in flush rate of 123I-beta-methyl-P-iodophenyl-pentadecanoic acid(BMIPP) myocardial scintigram SPECT from the baseline to the week 24 after the start of the treatment 2)Blood proteomic profile (predicted incidence of 4-year cardiovascular events with 27 proteins based on proteomic analysis results using SomaScan) the items, 3-9 below 3)Personal Health Record(PHR) information (sleep time, exercise (steps or distance traveled), resting heart rate, resting respiratory rate) 4)Blood tests (lipid, liver function, renal function, BNP, carnitine,TMAO, etc.) 5)Blood proteomic profile (proteomic index measured by SomaScan) 6)Kansas City Cardiomyopathy Questionnairea(KCCQ) (overall summary score, clinical summary score, total symptom score) 7)Echocardiogram indices (left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular ejection fraction, left ventricular myocardial weight, left ventricular myocardial weight coefficient, left atrial volume, left atrial volume coefficient, global longitudinal strain, E/e', single cardiac output, cardiac index) 8)MR spectroscopy (MRS) index (Fat to Water ratio in the ventricular septal region) 9)99mTc-Methoxy-Isobutyl-Isonitrile(MIBI) Washout Rate 10)12-lead ECG (rhythm (sinus rhythm /atrial flutter / pacemaker rhythm / others),PR,QRS,QT,QTc,presence or absence of the following findings (atrioventricular block, left ventricular high potential, ST-T change (including negative T wave), left bundle branch block, right bundle branch block, axial deviation, abnormal Q wave) at 24 weeks) | — |
Contacts
Public ContactSakata Yasuhiko
National Cerebral and Cardiovascular Center
Outcome results
None listed