Beta-Blocker Withdrawal in Heart Failure with Preserved Ejection Fraction and Chronotropic Incompetence (BRILLIANT)

JRCT ID: jRCT1031210030

Registered date:09/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with preserved ejection fraction
• Date of first enrollment: 07/07/2021
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Beta-blocker withdrawal or dose reduction

Outcome(s)

• Primary Outcome: Change in peak oxygen consumption during exercise stress echocardiography from baseline to four-weeks after the intervention

Secondary Outcome

*Changes in the following parameters from baseline to four-weeks after the intervention will be assessed:
Heart rate during peak exercise
Cardiac output during peak exercise
Mitral s' during peak exercise
GLS during peak exercise
VE/VCO2 slope
NT-proBNP levels

*The following prognostic data will be also assessed:
Time to first heart failure hospitalization
Time to all-cause mortality
Time to cardiac death
Time to first heart failure hospitalization or all-cause mortality
Time to first heart failure hospitalization or cardiac death

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age equal to or more than 20 years old
2) Patients with established HFpEF or subjects who are suspected of HFpEF
3) Subjects who are treated with a pre-specified minimum dose of beta-blockers
5) Subjects who are able to keep cycle ergometry
exercise (0 watts) for more than 30 seconds
6) Patients who give written consent to participate in this study

Exclude criteria

1) Patients with mimic HFpEF:
More than mild aortic or mitral valve stenosis, more than moderate aortic or mitral valve regurgitation, history of left ventricular ejection fraction less than 40%, non-group II pulmonary hypertension, hypertrophic cardiomyopathy (except for apical hypertrophic cardiomyopathy), cardiac sarcoidosis, constrictive pericardititis
2) Patients with comorbidities contraindicated for exercise testing:
acute decompensated heart failure, acute coronary syndrome, severe coronary artery disease
3) Patients who are expected to have disadvantages in discontinuing beta-blockers:
History of old myocardial infarction, presence of obvious myocardial ischemia, appearance of new wall motion abnormality during exercise, history of hospitalization due to tachyarrhythmia within 6 months, Basedow's disease
4) Patients who cannot exercise their legs due to
abnormalities in joints, muscles, etc.
4) Patients who are judged to be unsuitable for th
e study by the investigators

Related Information

• Primary Sponsor: Obokata Masaru