Cancer, Hypertension, Melanoma, Renal Cell Carcinoma
Conditions
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.
Interventions
DIAGNOSTIC_TESTAmbulatory 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.
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Blood Pressure | Baseline and 1 month | Mean 24 hour blood pressure from ambulatory 24 hour recording |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VEGF Inhibitor Alone 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. | 0 |
| Immune Checkpoint Inhibitor (ICI) Alone 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. | 1 |
| Combination (VEGF Inhibitor + ICI, or Combination of ICI) 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. | 1 |
| No Treatment 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. | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Immune Checkpoint Inhibitor (ICI) Alone | Combination (VEGF Inhibitor + ICI, or Combination of ICI) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 1 | 0 / 0 |
Outcome results
Primary
Change in Mean Blood Pressure
Mean 24 hour blood pressure from ambulatory 24 hour recording
Time frame: Baseline and 1 month
Population: Data analysis was not completed because only one participant completed the study and disclosing data could violate privacy interests.
Secondary
Ratio of Post-treatment to Pre-treatment Change in Digital Pulse Amplitude
Digital pulse amplitude will be measured using peripheral artery tonometry
Time frame: Baseline and 1 month
Population: Data analysis was not completed because only one participant completed the study and disclosing data could violate privacy interests.