Thiamine-HF trial

JRCT ID: jRCT1051230004

Registered date:09/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: heart failure with VB1 deficiency
• Date of first enrollment: 22/05/2023
• Target sample size: 118
• Study type: Interventional

Intervention(s)

Enrolled cases will be randomly assigned to [control treatment group: short-term VB1 supplementation therapy (oral administration of fursultiamine hydrochloride tablets 50mg/day for 2 weeks)] or [new treatment group: long-term VB1 supplementation therapy(oral administration of fursultiamine hydrochloride tablets 50mg/day for 52 weeks)]. Each treatment period will then be administered according to the assignment, and the incidence of complex cardiac events (cardiovascular death or HHF) during the 1-year observation period will be compared to verify superiority.
Screening period: Period from obtaining informed consent to registration.
Study treatment period: Period from the start date of study treatment to the date of final treatment after registration.
New treatment group: 1 year from the start of treatment (52 weeks + 4 weeks).
Control treatment group: 2 weeks from the start of treatment.

Outcome(s)

• Primary Outcome: The time to first event of cardiovascular death or HHF within 52 weeks.

Secondary Outcome

1.Time to cardiovascular death within 52 weeks.
2.Time to first onset of HHF within 52 weeks.
3.Time to all causes of death within 52 weeks.
4.Change from baseline in BNP after 13, 26, and 52 weeks
of study treatment.
5.Change from baseline in the following echocardiographic indices after 13 and 52 weeks of study treatment:
-Left ventricular end-diastolic volume index (LVEDVI)
-Left ventricular end-systolic volume index (LVESVI)
-Left ventricular ejection fraction (LVEF)
-Transtricuspid pressure gradient (TR-PG).
6.Change from baseline in pyruvate after 13, 26, and 52
weeks of study treatment.
7.Change from baseline in prognostic nutritional index (PNI) after 13, 26, and 52 weeks of study treatment.
8.Change from baseline in grip strength (kg) after 13, 26, and 52 weeks of study treatment.
9.Change from baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ) after 52 weeks of study treatment.

Key inclusion & exclusion criteria

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

Include criteria

Patients who meet all of the following criteria are eligible:
(1)Age 18 years or older at time of providing informed consent.
(2)Patients with VB1 deficiency (< 28 ng/mL).
(3)Outpatients with stage C heart failure.
(4)Patients receiving at least one standard drug for chronic heart failure (ACEI/ARB/ARNI, MRA, beta-blocker, SGLT2 inhibitor).
(5)Patients who understand the study protocol by documents and agree to participate in this study under their written consent.

Exclude criteria

(1)New initiation of standard treatment drugs (ACEI/ARB/ARNI, MRA, beta-blocker, SGLT2 inhibitor) for chronic heart failure from 4 weeks before consent (including the same day of the week 4 weeks before) until registration, or undergoing dose modification.
(2)Any severe valvular heart disease (according to the severity classification of the Guidelines on the Management of Valvular Heart Disease).
(3)Any congenital heart disease.
(4)Impaired renal function, defined as eGFR <20 mL/min/1.73 m2.
(5)Peripheral or central neuropathy.
(6)Unresolved malignant tumors.
(7)Active infectious disease.
(8)Patients otherwise judged necessary to be excluded by the investigator.

Related Information

• Primary Sponsor: Tanaka Atsushi