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

NCT03709771 | Terminated Results

• 1 other identifier: 181796
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma; Hypertension; Melanoma; Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Mean Blood Pressure

  Mean 24 hour blood pressure from ambulatory 24 hour recording

  Baseline and 1 month

Secondary Outcomes (1)

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

  Baseline and 1 month

Study Arms (4)

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

Interventions

Ambulatory Blood Pressure Measurement DIAGNOSTIC_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.

Combination (VEGF inhibitor + ICI, or combination of ICI); Immune Checkpoint Inhibitor (ICI) alone; No treatment; VEGF inhibitor alone

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Hypertension; Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Emily Shardelow
• Organization: Vanderbilt University Medical Center

emily.m.shardelow@vumc.org

615-875-8949

Study Officials

• Joshua Beckman, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: January 9, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 12, 2024
• Results First Posted: January 12, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)