PEMA-HF

JRCT ID: jRCTs051240124

Registered date:17/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure Complicated by Diabetes and Hypertriglyceridemia
• Date of first enrollment: 17/09/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): 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 physician according to the guidelines. If the fasting blood triglyceride level is 150 mg/dL or higher at Visit 3, increase the dose to 2 tablets of pemafibrate 0.1 mg tiwce a day.

Outcome(s)

• Primary Outcome: 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 Outcome

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 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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 16 weeks prior to obtaining consent
4) Patients diagnosed with chronic heart failure who meet the following at any time within 52 weeks prior to obtaining consent
BNP greater than or equal 100 pg/mL or NT-proBNP greater than or equal 300 pg/mL
And also Left ventricular ejection fraction (LVEF) <50%
5) Patients receiving Sodium glucose transporter2(SGLT2) inhibitors (including combination agents) for more than 12 weeks prior to obtaining consent
6) Patients with a reduced flush rate (<10%) in beta-methyl-P-iodophenyl-pentadecanoic acid(BMIPP) at any time within 16 weeks prior to obtaining consent
7) Patients who provide written informed consent

Exclude criteria

1. Patients who have a history of taking fibrates or pemafibrate
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 endogenic metals for whom MR spectroscopy (MRS) imaging is not possible
11. Patients with a history of acute coronary syndrome, myocarditis, or takotsubo-type cardiomyopathy within 24 weeks prior to obtaining consent
12. 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
13. Patients who have undergone or are scheduled to undergo coronary angioplasty within 12 weeks prior to obtaining consent
14. Patients with a history of hypersensitivity to pemafibrate
15. Patients receiving cyclosporine and rifampicin
16. Pregnant women, lactating women, or men and women who are unable to consent to contraception during the trial
17. Patients who have already participated in other clinical trials or plan to participate during the study period
18. Patients who are judged by the Principal Investigator or Co-Investigator to be inappropriate for participation in the Study for any other reason

Related Information

• Primary Sponsor: Takeshi Kitai
• Source(s) of Monetary Support: Kowa Corporation