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NCT03709771 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03709771
Other study ID # 181796
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 9, 2020
Est. completion date October 1, 2020

Study information
Verified date April 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ambulatory Blood Pressure Measurement
Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement. Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Mean Blood Pressure Mean 24 hour blood pressure from ambulatory 24 hour recording Baseline and 1 month
Secondary Ratio of Post-treatment to Pre-treatment Change in Digital Pulse Amplitude Digital pulse amplitude will be measured using peripheral artery tonometry Baseline and 1 month
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