The Impact of Nebivolol Versus Metoprolol on Quality of Life
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.
|Transplant; Failure, Kidney Hypertension||Drug: Nebivolol Drug: Metoprolol succinate|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
|Official Title:||The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients|
- Quality of Life [ Time Frame: 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) ]
Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires. The four quality of life questionnaires that were used included the following:
- Short Form (SF)-36v2 Health Survey (Score Range = 0-100; the lower the score the more disability)
- Sexual Dysfunction Tool for Men = International Index of Erectile Function (IIEF) Questionnaire (Score Range = 5-25; a score of 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction)
- Sexual Dysfunction Tool for Women = Changes in Sexual Functioning Questionnaire (CSFQ-14-F; Score Range = 14-70; a score at or below 42 is indicative of sexual dysfunction)
- Multidimensional Assessment of Fatigue (MAF) Scale (Score Range = 1-50; the higher the score the more fatigue)
- Blood Pressure [ Time Frame: 12 weeks ]Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.
|Study Start Date:||February 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Nebivolol||
Subject will take nebivolol daily for 12 weeks.
Other Name: Bystolic
|Active Comparator: Metoprolol Succinate||
Drug: Metoprolol succinate
Subject will take metoprolol succinate daily for 12 weeks.
Other Name: Toprol XL
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441570
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Burlington, Massachusetts, United States, 01805|
|Principal Investigator:||Steven Gabardi, PharmD, FCCP, BCPS||Transplant Surgery|