The Clinical Trial of Tamibarotene for Patients With HFpEF (RELIEF Trial)

ConditionHFpEF - Heart Failure With Preserved Ejection Fraction

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age26+

SponsorNagoya University

About this trial

This study will evaluate the effect of 12 weeks of treatment with tamibarotene compared with placebo on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients with heart failure with preserved ejection fraction (HFpEF).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patients who have been diagnosed with heart failure at least 12 weeks prior to providing informed consent and are classified as NYHA Class II to IV at screening.

2. Patients with LVEF of 50% or more as determined by echocardiography at screening.

3. Patients with an NT-proBNP level of 300 pg/mL or more at screening (or 600 pg/mL or more for patients with atrial fibrillation at screening).

4. Patients have evidence of structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) based on echocardiography at screening, or who have a history of hospitalization for heart failure within 12 months prior to providing informed consent.

Disqualifiers

1. Patients diagnosed with acute heart failure, atrial fibrillation, or atrial flutter with a resting heart rate greater than 110 bpm within 4 weeks prior to enrollment.

2. Patients with a history of myocardial infarction or unstable angina within 12 weeks prior to enrollment.

3. Patients with chronic heart failure attributable to cardiac amyloidosis, glycogen storage disease, hypertrophic cardiomyopathy, active myocarditis, mitochondrial cardiomyopathy, cardiac sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, constrictive endocarditis, cardiac tamponade, untreated severe valvular heart disease, congenital heart disease, or other similar conditions.

4. Patients who have undergone PCI, CABG, valvuloplasty, valve replacement surgery, catheter ablation, implantation of an ICD, CRT, or any other cardiac surgery within 12 weeks prior to enrollment, or who are expected to require any of these procedures during the study period.

Trial design

Design model

Parallel

Treatments tested in this trial

Tamibarotene
Drug
Tamibarotene 4 mg is administered orally once daily after breakfast for 12 weeks.
Placebo
Drug
Placebo is administered orally once daily after breakfast for 12 weeks.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: TamibaroteneExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change From Baseline in serum NT-proBNP

Time frame

Baseline, 4 weeks, 12 weeks, 16 weeks

Secondary outcomes

Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure

Time frame

Up to 16 weeks

Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Left Atrial Dimension.

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters.

Time frame

Baseline, 4 weeks, 12 weeks, 16 weeks

Change From Baseline in Echocardiography Parameters: Left Atrial Volume (LAV), LAV Index, Left Ventricular Ejection Fraction, Left Ventricular Mass (LVM), LVM Index, Tricuspid Regurgitation Velocity

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters.

Time frame

Baseline, 4 weeks, 12 weeks, 16 weeks

Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus, Ratio of E to A Velocity, E/e' Ratio

A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters.

Time frame

Baseline, 4 weeks, 12 weeks, 16 weeks

Other outcomes

sST2、serum TIMP-1、serum Meflin

Time frame

Baseline, 4 weeks, 12 weeks, 16 weeks

Grip strength

Time frame

Baseline, 4 weeks, 12 weeks, 16 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nagoya University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: