Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT03709771
  4. Details
NCT03709771 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03709771
Other study ID # 181796
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 9, 2020
Est. completion date October 1, 2020

Study information
Verified date April 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Mean Blood Pressure Mean 24 hour blood pressure from ambulatory 24 hour recording Baseline and 1 month
Secondary Ratio of Post-treatment to Pre-treatment Change in Digital Pulse Amplitude Digital pulse amplitude will be measured using peripheral artery tonometry Baseline and 1 month
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A