Thiamine-HF trial

Phase 3

Recruiting

• Conditions: heart failure with VB1 deficiency

• Registration Number: JPRN-jRCT1051230004
• Lead Sponsor: Tanaka Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 118

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to first event of cardiovascular death or HHF within 52 weeks.

Secondary Outcome Measures

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