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OpenTrials
Completed

NCT Number: NCT01125943

Bevacizumab and Endothelium Dependent Vasodilation

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.

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Key information

Conditions

Hypertension Cancer Cardiovascular Diseases Endothelial Dysfunction Neoplasms Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-50 years old
  • Male
  • Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion criteria

  • Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
  • History of or current abuse of drugs, alcohol or solvents.
  • History of malignant disease.
  • First degree relatives with a history of cancer before the age of 50
  • First degree relatives with a history of premature cardiovascular disease before the age of 50
  • Current use of medication.
  • Clinical evidence of cardiac or pulmonary disease
  • Hypertension ( systole >140mmHG, diastole >90mmHg)
  • Diabetes mellitus
  • Smoking
  • Any clinically relevant abnormality on ECG.
  • A history of thrombosis or first degree family members with a history of recurrent thrombosis
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Previous participation in a study with bevacizumab

Treatment and study plan

Acetylcholine

Drug

Intra-arterial infusion

nitroprusside

Drug

Intra arterial infusion

Bevacizumab

Drug

Intra arterial infusion

Primary outcomes

  1. Vasomotor response assessed by venous occlusion strain gauge plethysmography

    Time frame: 15 minutes

    Response to infusion of bevacizumab and/or acetylcholin or nitroprusside

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Cancer Society

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 19, 2010
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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