Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Renal Cell

Hypertension

Vascular Diseases

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

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.

Ambulatory Blood Pressure Measurement

Joshua Beckman, MD

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.

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

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Mean 24 hour blood pressure from ambulatory 24 hour recording

Digital pulse amplitude will be measured using peripheral artery tonometry

Vanderbilt University Medical Center

Professor

There were no participants in the other two arms (VEGF alone and no treatment) and therefore there were no participants at risk in those arms.

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.

VEGF Inhibitor Alone

Immune Checkpoint Inhibitor (ICI) Alone

Combination (VEGF Inhibitor + ICI, or Combination of ICI)

No Treatment

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Data analysis was not completed because only one participant completed the study and disclosing data could violate privacy interests.

Emily Shardelow

Change in Mean Blood Pressure

Ratio of Post-treatment to Pre-treatment Change in Digital Pulse Amplitude

Overall Study

Spots Global Cancer Trial Database for Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial