HypertensionNCT01125943
Bevacizumab and Endothelium Dependent Vasodilation
A study testing Acetylcholine, Nitroprusside and Bevacizumab in people with Hypertension and Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cancer, Endothelial Dysfunction
- What is being tested?
- Acetylcholine, Nitroprusside and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypertension, Cancer, Endothelial Dysfunction
- Being tested
- Acetylcholine, Nitroprusside, Bevacizumab
- Medical subject headings
- Hypertension, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcholineDrug
Intra-arterial infusion
NitroprussideDrug
Intra arterial infusion
BevacizumabDrug
Intra arterial infusion
| Study group | Role | What they receive |
|---|---|---|
| Acetylcholine | Experimental | Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab Receives: Drug: Acetylcholine; Drug: Bevacizumab |
| Nitroprusside | Experimental | Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab Receives: Drug: Nitroprusside; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasomotor response assessed by venous occlusion strain gauge plethysmography
Response to infusion of bevacizumab and/or acetylcholin or nitroprusside
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, G. Rongen, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125943
- Sponsor's protocol ID
- BVZAch
- Status last verified
- Jan 2013
- First submitted
- 17 May 2010
- Last updated
- 10 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Endothelium Dependent Vasodilation
- ClinicalTrials.gov ID
- NCT01125943
- Acronym / sponsor ID
- BVZAch
- Conditions
- Hypertension, Cancer, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylcholine | Experimental | Drug: Acetylcholine, Drug: BevacizumabIntra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab |
| Nitroprusside | Experimental | Drug: Nitroprusside, Drug: BevacizumabInfusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetylcholineIntra-arterial infusion | Drug | Acetylcholine |
| NitroprussideIntra arterial infusion | Drug | Nitroprusside |
| BevacizumabIntra arterial infusion | Drug | Acetylcholine, Nitroprusside |
Primary outcome
Vasomotor response assessed by venous occlusion strain gauge plethysmography
Time frame: 15 minutes
Response to infusion of bevacizumab and/or acetylcholin or nitroprusside
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetylcholine, Nitroprusside and Bevacizumab in people with Hypertension and Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasomotor response assessed by venous occlusion strain gauge plethysmography (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.