Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease

Vanderbilt University Medical Center

Status: Terminated

Conditions: Hypertension; Melanoma; Cancer; Renal Cell Carcinoma

Treatments: Diagnostic Test: Ambulatory Blood Pressure Measurement

Study type: Observational

Funder types: Other

Identifiers

NCT03709771

181796

Details and patient eligibility

About

The purpose of this study is to understand the effect of vascular endothelial growth factor tyrosine kinase (VEGF) inhibitor, immune checkpoint-inhibitor (ICI), and combination treatment on blood pressure and blood vessel function.

Enrollment: 2 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age 40 - 75 years old
• Diagnosis of cancer
• Receiving VEGF inhibitor, ICI, or combination (VEGF inhibitor + ICI or combination ICI) treatment, or not receiving any treatment.
• Normal blood pressure or blood pressure treated to < 140/90 mm Hg with ≤2 antihypertensive medications

Exclusion criteria

• Presence of peripheral artery disease
• History of a heart attack within 1 year
• History of a stroke within 1 year
• Diabetes
• Life expectancy < 3 months
• Women who are pregnant
• Women who are nursing

Trial design

2 participants in 4 patient groups

VEGF inhibitor alone

Treatment:

Diagnostic Test: Ambulatory Blood Pressure Measurement

Immune Checkpoint Inhibitor (ICI) alone

Treatment:

Diagnostic Test: Ambulatory Blood Pressure Measurement

Combination (VEGF inhibitor + ICI, or combination of ICI)

Treatment:

Diagnostic Test: Ambulatory Blood Pressure Measurement

No treatment

Treatment:

Diagnostic Test: Ambulatory Blood Pressure Measurement