The Impact of Nebivolol Versus Metoprolol on Quality of Life

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:	Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:	No
Age Range:	18 - 75
Updated:	5/27/2013
Start Date:	February 2012
End Date:	January 2014
Contact:	Steven Gabardi, PharmD, FCCP, BCPS
Email:	sgabardi@partners.org
Phone:	978-447-1637

The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients

In an open label analysis, nebivolol has been shown to have a positive impact on quality of
life in the general hypertensive population. That is, patients treated with nebivolol
reported less side effects compared to those treated with metoprolol. Also, more nebivolol
treated patients reached normalization of blood pressure. Although there is no data, it is
believed that the impact would be similar in renal transplant recipients.

The primary goal of this study is to determine if nebivolol will improve the quality of life
measurements of kidney transplant recipients as compared to those treated with metoprolol
succinate. This will be measured by comparing the scores of four quality of life
questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of
this study are to determine if the use of nebivolol is cost-effective in the renal
transplant recipient; determine if there is a change in urine protein excretion and renal
function with the use of nebivolol; and determine the number of patients that maintain or
achieve a target blood pressure of ≤ 120/80 mmHg.

Inclusion Criteria:

- Adult renal transplant recipients, men and women between 18 and 75 years of age,
inclusive.

- Patients must be > 3 months post-transplant.

- Patients must have stable renal function (stable renal function will be defined as
those patients without infection or hospitalization [for any reason] over the past 30
days, and patients with < 20% change in their serum creatinine over the past 30 days.

- Patients receiving corticosteroids must be receiving a daily dose of < 7.5 mg of
prednisone (or therapeutic equivalents based on glucocorticoid equivalency scale).

- All eligible patients must be receiving antihypertensive medication management which
must include metoprolol tartrate or metoprolol succinate.

- Patients may be on more than one medication to control their hypertension. Use of any
other FDA-approved antihypertensive agent is permitted.

- All eligible patients will either be at goal blood pressure (<120/80 mmHg) or have
Pre-hypertension (<140/90 mmHg) or Stage I hypertension (<160/100 mmHg) at the time
of study inclusion.

- Patients who are able to comprehend and satisfactorily comply with protocol
requirements.

- Patients who signed the written informed consent given prior to entering any study
procedure.

Exclusion Criteria:

- Patients with Stage II/uncontrolled hypertension (>159/99 mmHg).

- Patients with an easily identifiable etiology for fatigue (i.e. anemia,
iron-deficiency, poor sleep patterns, etc.).

- Patients who have a medical condition that, in the Investigator's opinion, would
expose them to an increased risk of a significant adverse event or interfere with
assessments of safety and efficacy during the course of the trial (i.e. arrhythmia).

- Patients with any current malignancy, or any clinically significant hematological,
endocrine, cardiovascular, hepatic, gastrointestinal or neurological disease
(including any form of epilepsy). If there is a history of such disease but the
condition has been stable for at least the past year and is judged by the
investigator not to interfere with the patient's participation in the study, the
patient may be included.

- Patients who are judged by the investigator to be unable or unlikely to follow the
study protocol and complete all scheduled visits.

- Patients with any contraindications to beta blocker therapy as listed in the package
labeling for both metoprolol succinate and nebivolol.

We found this trial at

sites

Brigham and Women's Hosp

75 Francis street
Boston, Massachusetts 02115

(617) 732-5500