NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1031210030

Registered date:09/04/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHeart failure with preserved ejection fraction
Date of first enrollment07/07/2021
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)Beta-blocker withdrawal or dose reduction

Outcome(s)

Primary OutcomeChange 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 maximumNot applicable
GenderBoth
Include criteria1) 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 criteria1) 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, 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

Contact

Public contact
Name Masaru Obokata
Address 3-39-15 Showa-machi, Maebashi, Gunma Gunma Japan 371-8511
Telephone +81-272208145
E-mail obokata.masaru@gunma-u.ac.jp
Affiliation Gunma University Hospital
Scientific contact
Name Masaru Obokata
Address 3-39-15 Showa-machi, Maebashi, Gunma Gunma Japan 371-8511
Telephone +81-272208145
E-mail obokata.masaru@gunma-u.ac.jp
Affiliation Gunma University Hospital