Renal Cell CarcinomaNCT03709771
Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease
An observational study of Renal Cell Carcinoma and Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma, Hypertension, Melanoma
- What is being tested?
- Ambulatory Blood Pressure Measurement
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with cancer that will be receiving VEGF inhibitor, ICI, or combination (VEGF inhibitor plus ICI or combination ICI treatment), or not receiving any treatment.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
- Conditions
- Renal Cell Carcinoma, Hypertension, Melanoma, Cancer
- Being tested
- Ambulatory Blood Pressure Measurement
- Medical subject headings
- Carcinoma, Renal Cell, Hypertension, Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Blood Pressure MeasurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| VEGF inhibitor alone | Not described Receives: Diagnostic Test: Ambulatory Blood Pressure Measurement | |
| Immune Checkpoint Inhibitor (ICI) alone | Not described Receives: Diagnostic Test: Ambulatory Blood Pressure Measurement | |
| Combination (VEGF inhibitor + ICI, or combination of ICI) | Not described Receives: Diagnostic Test: Ambulatory Blood Pressure Measurement | |
| No treatment | Not described Receives: Diagnostic Test: Ambulatory Blood Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Blood Pressure
Mean 24 hour blood pressure from ambulatory 24 hour recording
Measured: Baseline and 1 month
Secondary outcomes (1)
Ratio of Post-treatment to Pre-treatment Change in Digital Pulse Amplitude
Digital pulse amplitude will be measured using peripheral artery tonometry
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start9 Jan 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: Study terminated due to unmet targeted accrual goals with only 2 subjects accrued out of 80 planned due to COVID-19 and the PI on the grant leaving VUMC in October 2021.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Beckman, Vanderbilt University Medical Center
- Investigators
- Joshua Beckman, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709771
- Sponsor's protocol ID
- 181796
- Status last verified
- Apr 2023
- First submitted
- 15 Oct 2018
- Last updated
- 12 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03709771
- Acronym / sponsor ID
- 181796
- Conditions
- Renal Cell Carcinoma, Hypertension, Melanoma, Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to unmet targeted accrual goals with only 2 subjects accrued out of 80 planned due to COVID-19 and the PI on the grant leaving VUMC in October 2021.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VEGF inhibitor alone | – | Diagnostic Test: Ambulatory Blood Pressure Measurement |
| Immune Checkpoint Inhibitor (ICI) alone | – | Diagnostic Test: Ambulatory Blood Pressure Measurement |
| Combination (VEGF inhibitor + ICI, or combination of ICI) | – | Diagnostic Test: Ambulatory Blood Pressure Measurement |
| No treatment | – | Diagnostic Test: Ambulatory Blood Pressure Measurement |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with cancer that will be receiving VEGF inhibitor, ICI, or combination (VEGF inhibitor plus ICI or combination ICI treatment), or not receiving any treatment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory Blood Pressure MeasurementBaseline: 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. | Diagnostic test | Combination (VEGF inhibitor + ICI, or combination of ICI), Immune Checkpoint Inhibitor (ICI) alone, No treatment, VEGF inhibitor alone |
Primary outcome
Change in Mean Blood Pressure
Time frame: Baseline and 1 month
Mean 24 hour blood pressure from ambulatory 24 hour recording
1 secondary outcome
Ratio of Post-treatment to Pre-treatment Change in Digital Pulse Amplitude
Time frame: Baseline and 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Beckman, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Hypertension, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Blood Pressure (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.