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The Impact of Nebivolol Versus Metoprolol on Quality of Life

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transplant; Failure, Kidney; Hypertension

Intervention: Nebivolol (Drug); Metoprolol succinate (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Steven Gabardi, PharmD, FCCP, BCPS, Principal Investigator, Affiliation: Transplant Surgery


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Quality of Life

Secondary outcome:

Blood Pressure


Urine Protein and calculated GFR


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

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


- 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


- 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.

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Lahey Clinic, Burlington, Massachusetts 01805, United States

Additional Information

Starting date: February 2012
Last updated: July 15, 2013

Page last updated: August 23, 2015

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