Effects Of The Administration Of Nebivolol Versus Carvedilol On Microcirculatory Endothelial Function, Arterial Stiffness And Wave Reflection In Healthy Volunteers” (NeCaMic-study) - NeCaMic

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014643-36-BE

Enrollment

Unknown

Registered

2010-03-15

Start date

2010-04-23

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcirculatory Endothelial Function, Arterial Stiffness And Wave Reflection

Interventions

Trade Name: Nobiten Product Name: nebivolol Product Code: C07AB12 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Capsul

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Male volunteers • = 18 year old at the randomisation visit and = 75 year old • Normotensive volunteers : SBP 60 BPM Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Cardiovascular disease (such as unstable angina, sick sinus syndrome, heart failure with LVEF 2.5 mg/dl • Creatinine clearance35 kg/m²) • Cannabis or other drug abuse • Use of anti-inflammatory drugs within the past 2 weeks even topically apply • Excessive use of Alcohol (at the discretion of the Investigator)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objective of the study is to evaluate the role of the EDHF (endothelium derived hyperpolarizing factor) pathway in the beneficial microvascular endothelial effects of Nebivolol and Carvedilol. ; Main Objective: The primary objective of this study is to assess the effects of 7 days treatment of Nebivolol and Carvedilol on the skin microvascular endothelial function, arterial stiffness and wave reflection to the aorta in healthy volunteers. ; Primary end point(s): The primary objective of this study is to assess the effects of 7 days treatment of Nebivolol and Carvedilol on the skin microvascular endothelial function, arterial stiffness and wave reflection to the aorta in healthy volunteers. This primary objective will be assessed through the endpoints: • Skin microvascular blood flow after Acetylcholine iontophoresis on skin pretreated with intradermal injection of saline: (Endothelial dependent vasodilatation, Nebivolol versus Carvedilol effect compared to baseline). • Skin microvascular blood flow after Nitroprusside iontophoresis on skin pretreated with intradermal injection of saline (Endothelial independent vasodilatation, Nebivolol versus Carvedilol effect compared to baseline). • Pulse wave velocity (Nebivol versus Carvedilol effect compared to baseline). • Aortic augmentation Index (Nebivolol versus Carvedilol effect compared to baseline).	—

Measure

Time frame

Secondary Objective: The secondary objective of the study is to evaluate the role of the EDHF (endothelium derived hyperpolarizing factor) pathway in the beneficial microvascular endothelial effects of Nebivolol and Carvedilol. ; Main Objective: The primary objective of this study is to assess the effects of 7 days treatment of Nebivolol and Carvedilol on the skin microvascular endothelial function, arterial stiffness and wave reflection to the aorta in healthy volunteers. ; Primary end point(s): The primary objective of this study is to assess the effects of 7 days treatment of Nebivolol and Carvedilol on the skin microvascular endothelial function, arterial stiffness and wave reflection to the aorta in healthy volunteers. This primary objective will be assessed through the endpoints: • Skin microvascular blood flow after Acetylcholine iontophoresis on skin pretreated with intradermal injection of saline: (Endothelial dependent vasodilatation, Nebivolol versus Carvedilol effect compared to baseline). • Skin microvascular blood flow after Nitroprusside iontophoresis on skin pretreated with intradermal injection of saline (Endothelial independent vasodilatation, Nebivolol versus Carvedilol effect compared to baseline). • Pulse wave velocity (Nebivol versus Carvedilol effect compared to baseline). • Aortic augmentation Index (Nebivolol versus Carvedilol effect compared to baseline).

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026