Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab

• Status: Withdrawn
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Mississippi Medical Center
• Treatments: Bevacizumab; Lisinopril; Nebivolol

Criteria

Inclusion Criteria:

• Patients currently treated at the University of Mississippi Medical Center Oncology Clinic

• Patient is being treated with bevacizumab either alone or in combination with other agents for cancer

• Patient blood pressure is >140 mmHg (systolic) or > 90 mmHg (diastolic), either treated or untreated with medications for hypertension

• Patients may be currently on medications for hypertension (other than Beta blocker, ACEI, or ARB); these will be continued at the same dose throughout the study

• Patients should be > 18 years of age

• Patients receiving bevacizumab therapy approximately every 2 weeks

Exclusion Criteria:

• History of ACEI or ARB induced angioedema or idiopathic/hereditary angioedema

• Patient currently treated with a Beta blocker, ACEI, or ARB or have a history of intolerance to a medication in any of these classes

• Hyperkalemia, defined as a potassium value of >5 mEq/L

• Pregnancy or breastfeeding

• Severe renal impairment (eGFR <30 mL/min)

• Moderate hepatic impairment as identified by physician

• Currently taking CYP2D6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.)

• History of clinically significant EKG abnormality which would contraindicate beta blocker use

• Recent stroke (<6 months)

• Recent myocardial infarction (<6 months)

• Congestive heart failure

• Severe asthma or COPD

• Diagnosed obstructive sleep apnea