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

Terminated

• Conditions: Renal Cell Carcinoma; Hypertension; Melanoma; Cancer
• Interventions: Diagnostic Test: Ambulatory Blood Pressure Measurement

• Registration Number: NCT03709771
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2020-01-09
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2023-04
• Results First Submitted: 2023-04-12
• Results First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Results First Posted: 2024-01-12
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combination (VEGF inhibitor + ICI, or combination of ICI)	Ambulatory Blood Pressure Measurement	-
VEGF inhibitor alone	Ambulatory Blood Pressure Measurement	-
Immune Checkpoint Inhibitor (ICI) alone	Ambulatory Blood Pressure Measurement	-
No treatment	Ambulatory Blood Pressure Measurement	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Blood Pressure	Baseline and 1 month	Mean 24 hour blood pressure from ambulatory 24 hour recording

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States