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

Study Overview
=================
Brief 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.

Official Title
-----------------
Comparative Blood Pressure Effects of Nebivolol Versus Lisinopril in Patients With New Onset or Exacerbated Hypertension Induced by Bevacizumab: a Crossover Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nebivolol
* Drug: Lisinopril


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nebivolol<br>Nebivolol 5 mg daily for 2 weeks, then 5 or 10 mg daily for 2 weeks | Drug: Nebivolol<br>* Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks<br>|
| Active Comparator: Lisinopril<br>20 mg once daily for 2 weeks, then 20 or 40 mg once daily for 2 weeks | Drug: Lisinopril<br>* Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study will be changes in sitting systolic and diastolic blood pressure at the crossover and final visits. | Patients will be treated with both nebivolol or lisinopril for a period of 4 weeks, and then crossover to the opposite medication for an additional 4 weeks. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint of the study will be changes in heart rate at the end of the crossover and final visits. | Patients will be treated with both nebivolol or lisinopril for a period of 4 weeks, and then crossover to the opposite medication for an additional 4 weeks. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension as a result of bevacizumab therapy