Clinical trial NCT01441570: The Impact of Nebivolol Versus Metoprolol on Quality of Life
Official title: The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transplant; Failure, Kidney
Hypertension
Keywords: kidney
transplant
hypertension
nebivolol
metoprolol
bystolic
toprol
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
name: Lahey Clinic
First posted: 2011-09-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life
timeFrame: 12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 - End of week 12)
Secondary outcomes:
measure: Blood Pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Transplant Surgery
name: Steven Gabardi, PharmD, FCCP, BCPS
role: PRINCIPAL_INVESTIGATOR
References: