JPRN-jRCT1031210030
Recruiting
Phase 2
Beta-Blocker Withdrawal in Heart Failure with Preserved Ejection Fraction and Chronotropic Incompetence (BRILLIANT): A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Trial - BRILLIANT trial
Obokata Masaru0 sites150 target enrollmentApril 9, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Obokata Masaru
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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, 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
Outcomes
Primary Outcomes
Not specified
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