Clinical trial · Observational
Endothelial Effects of VEGF Inhibition In Vivo in Man
Novel Cancer Chemotherapeutics and the Vasculature: Endothelial Effects of VEGF Inhibition In Vivo in Man
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Recent developments in chemotherapy, particularly VEGF-inhibitor (VEGFI) drugs, have markedly improved the prognosis of patients with cancer. However, these drugs frequently cause high blood pressure (hypertension) which can lead to heart attacks, heart failure and stroke and can limit their use for cancer treatment. Endothelin-1 is a hormone that causes blood vessels to tighten and may contribute to high blood pressure associated with VEGFI drugs. Blocking the effects of endothelin-1 may therefore reduce or prevent VEGFI-associated blood pressure changes, although this has never been tested in humans. Our long-term goal is to assess the protective effects of endothelin-1 blocker drugs in patients treated with VEGFI. Before doing so, we must better explore whether VEGFIs cause blood vessel narrowing and if endothelin-1 blockers prevent this. We will assess this in healthy volunteers using a special technique called 'forearm plethysmography'. We will examine the effect of VEGFI on blood flow and also the effect of simultaneous administration of endothelin-1 blockers. These will be given at doses that produce local effects in the arm without affecting the rest of the body. These studies study will show whether endothelin-1 blockers may help treat VEGFI-associated hypertension to enable more patients safely to receive vital cancer treatments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in forearm blood flow
- timeFrame
- 105 minutes
- description
- Study drugs will be infused intra-arterially and forearm arterial blood flow assessed using forearm venous occlusion plethysmography expressed as ml per 100 ml of forearm volume per minute
Secondary outcomes (2)
- measure
- Change in plasma concentration of t-PA
- timeFrame
- 105 minutes
- description
- Change in plasma concentration of t-PA measured as units/mL
- measure
- Change in plasma concentration of PAI-1
- timeFrame
- 105 minutes
- description
- Change in plasma concentration of PAI-1 measured as units/mL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * healthy volunteer male * aged between 18 and 64 years Exclusion Criteria: * Unable to provide written, informed consent * Unable or unwilling to attend for study assessments * Current involvement in a clinical trial * Severe or significant co-morbidity including: * Hypertension * Hyperlipidaemia * Cerebrovascular disease * Ischaemic heart disease or heart failure * Arial fibrillation/flutter * Venous or arterial thrombotic/thromboembolic event * Renal failure * Hepatic failure * Use of any prescription medication or non-steroidal anti-inflammatory drugs within the 3 days prior to vascular assessments * Cigarette smoker or tobacco use * Recreational drug use * History of anaemia * History of cancer * History of macular degeneration * Ongoing inflammatory, infective or autoimmune disease * Live vaccination received in the 3 months before the study, or expected to be required in the 6 months after the study * Unable or unwilling to use contraception with female partners in the 6 months after the study * BMI \> 35 kg/m2 * Unable to avoid blood donation for 1 week after the study
References
Publications (0)
Data not yet available