Bevacizumab and Endothelium Dependent Vasodilation

Hypertension Clinical Trial

Official title:

Bevacizumab and Endothelium Dependent Vasodilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125943
• Other study ID #: BVZAch
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: January 8, 2013
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.

The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Age 18-50 years old

2. Male

3. Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.

4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.

2. History of or current abuse of drugs, alcohol or solvents.

3. History of malignant disease.

4. First degree relatives with a history of cancer before the age of 50

5. First degree relatives with a history of premature cardiovascular disease before the age of 50

6. Current use of medication.

7. Clinical evidence of cardiac or pulmonary disease

8. Hypertension ( systole >140mmHG, diastole >90mmHg)

9. Diabetes mellitus

10. Smoking

11. Any clinically relevant abnormality on ECG.

12. A history of thrombosis or first degree family members with a history of recurrent thrombosis

13. Inability to understand the nature and extent of the trial and the procedures required.

14. Previous participation in a study with bevacizumab

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer
• Endothelial Dysfunction
• Hypertension

Intervention

Drug:
• Acetylcholine
Intra-arterial infusion
• Nitroprusside
Intra arterial infusion
• Bevacizumab
Intra arterial infusion

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasomotor response assessed by venous occlusion strain gauge plethysmography	Response to infusion of bevacizumab and/or acetylcholin or nitroprusside	15 minutes	No