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

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03709771
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Actual Duration (Months): 8.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma; Hypertension; Melanoma; Cancer	Diagnostic Test: Ambulatory Blood Pressure Measurement

Study Design

• Study Type: Observational
• Actual Enrollment: 2 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease
• Actual Study Start Date: Jan 9, 2020
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
VEGF inhibitor alone	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.
Immune Checkpoint Inhibitor (ICI) alone	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.
Combination (VEGF inhibitor + ICI, or combination of ICI)	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.
No treatment	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.

Outcome Measures

Primary Outcome Measures

1. Change in mean blood pressure [Baseline and 1 month]

   Mean 24 hour blood pressure from ambulatory 24 hour recording

Secondary Outcome Measures

1. Ratio of post-treatment to pre-treatment change in digital pulse amplitude [Baseline and 1 month]

   Digital pulse amplitude will be measured using peripheral artery tonometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Joshua Beckman, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joshua Beckman, Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03709771
• Other Study ID Numbers: 181796
• First Posted: Oct 17, 2018
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Carcinoma, Renal Cell; Hypertension; Cardiovascular Diseases

Study Results

No Results Posted as of Jul 18, 2022