This is a single-arm, open label, interventional, multi-center, phase IV pilot study.
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Locations near you
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Full eligibility criteria for NCT03026088
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
18-80 year, male or female.
Chronic Heart failure subjects with medical history of cardiac disease or other related cardiovascular disease.
Left ventricular ejection fraction (LVEF) less than or equal to (=<) 40 percent (%).
New York Heart Association (NYHA) class of II - IV
NYHA II ： Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation.
NYHA III：Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation.
NYHA IV：Unable to carry on any physical activity without discomfort. Symptoms at rest can be present. If any physical activity is undertaken, discomfort increased.
Signed Informed Consent Form (ICF).
Acute coronary syndrome (ACS) within 3 months.
Under beta-blocker treatment for the last 2 weeks.
Under other medicine treatment which may affect heart rate, like Non-dihydropyridine calcium channel blockers (NDHP-CCBs) or ivabradine for the last 2 weeks; Under Digoxin treatment [more than (>) 0.125 milligram (mg)].
Serum Alanine Aminotransferase (ALT) > triple the upper limit of the normal range; and/or
Serum Aspartate Aminotransferase (AST) > triple the upper limit of the normal value range and/or
Severe renal dysfunction, defined as:
Serum creatinine > twice the upper limit of the normal range
Chronic Kidney Disease (glomerular filtration rate <45 Milliliter per minute).
Hyperthyroidism or hypothyroidism.
Severe infectious disease, example (eg) Human Immunodeficiency Virus positive or active tuberculosis.
Severe autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
Severe respiratory, digestive, hematological disease (including Anemia of Hb < 100 gram per litre) or tumor.
Known to be hypersensitivity to Bisoprolol, or any of the excipient.
Substance or alcohol abuse.
Received heart transplantation or pacemaker implantation; revascularization treatment within 3 months; or plan to receive above treatment in 6 months.
Currently undertaking other treatment that may affect the safety and/or efficacy evaluation, e.g. beta receptors agonists, et cetera.
No legal ability or legal ability is limited.
Subjects unlikely to cooperate in the study or with inability or unwillingness to give informed consent.
Child-bearing period women without effective contraceptive measures, pregnancy and lactation.
Participation in another clinical trial within the past 90 days.
Other significant condition that in the Investigator's opinion would exclude the subject from the trial.
All locations for NCT03026088
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, China, 100037
View full eligibility
Tris trial is registered with FDA with number: NCT03026088. The sponsor of the trial is Merck KGaA, Darmstadt, Germany and it is looking for 26 volunteers for the current phase.
Official trial title: A Single-arm, Interventional, Multi-center, Pilot Study to Evaluate the Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Patients With NYHA Class II - IV (Biso-CHF Study)
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