The Impact of Nebivolol Versus Metoprolol on Quality of Life

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Transplant; Failure, Kidney
• Intervention / Treatment: Drug: Nebivolol; Drug: Metoprolol succinate

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nebivolol	Drug: Nebivolol; Subject will take nebivolol daily for 12 weeks.; Other Names: Bystolic
Active Comparator: Metoprolol Succinate	Drug: Metoprolol succinate; Subject will take metoprolol succinate daily for 12 weeks.; Other Names: Toprol XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.	12 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Forest Laboratories; Lahey Clinic
• Investigators: Principal Investigator: Steven Gabardi, PharmD, FCCP, BCPS, Transplant Surgery

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 27, 2011

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: transplant; hypertension; kidney; nebivolol; metoprolol; bystolic; toprol
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Hypertension; Renal Insufficiency; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-1 Receptor Agonists; Nebivolol; Metoprolol
• Other Study ID Numbers: 2011P001638