Clinical trial NCT04432610: Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects
Official title: Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects: a Randomized, Double-blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bisoprolol Adverse Reaction
Nebivolol Adverse Reaction
Lead sponsor: Clinical Hospital Center Zemun
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomized, double-blind, crossover study in healthy adult subjects. Each subject will receive a single dose of bisoprolol 5 mg p.o. and nebivolol 5 mg p.o. with 1 week washout period. All subjects will undergo a physical examination, 12-lead electrocardiography and a comprehensive echocardiographic study before the administration of the study drug and 5 hours thereafter.


Eligibility criteria: Inclusion Criteria:

1. Healthy subjects (male and female)
2. Age interval: 20-60 years old (inclusive)

Exclusion Criteria:

1. Any known absolute or relative contraindication to beta-blocker therapy
2. Poor echogenicity
3. A resting heart rate \<60 bpm
4. A resting blood pressure \< 110/70 mmHg

Primary outcomes:
measure: Relative change (%) of cardiac output (CO)
timeFrame: Pre- and 5 hours post study drug administration
Secondary outcomes:
measure: Absolute and relative changes of left ventricular ejection fraction (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of global longitudinal strain (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of myocardial work (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of atrial function (ml)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute change of myocardial dispersion (ms)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of TAPSE (tricuspid annular plane systolic excursion, mm)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of blood pressure (mmHg)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes in atrial strain (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of electrical dispersion (ms)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of right ventricular fractional area change (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of heart rate (bpm)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of left ventricular twist (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of QTc interval (ms)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of mitral E/A ratio (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative change of mitral E/e prime ratio (%)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative change of mitral E-wave deceleration time (ms)
timeFrame: Pre- and 5 hours post study drug administration
measure: Absolute and relative changes of right ventricular global longitudinal strain (%)
timeFrame: Pre- and 5 hours post study drug administration
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zemun
Study officials:
References: