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The Impact of Nebivolol Versus Metoprolol on Quality of Life

Primary Purpose

Transplant; Failure, Kidney, Hypertension

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nebivolol

Metoprolol succinate

About this trial

This is an interventional treatment trial for Transplant; Failure, Kidney focused on measuring kidney, transplant, hypertension, nebivolol, metoprolol, bystolic, toprol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Brigham and Women's Hospital
Lahey Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Nebivolol

Metoprolol Succinate

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Blood Pressure

Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.

Full Information

NCT ID

NCT01441570

First Posted

September 26, 2011

Last Updated

March 9, 2017

Sponsor

Brigham and Women's Hospital

Collaborators

Forest Laboratories, Lahey Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01441570

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

due to slow enrollment

Study Start Date

February 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

Forest Laboratories, Lahey Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transplant; Failure, Kidney, Hypertension

Keywords

kidney, transplant, hypertension, nebivolol, metoprolol, bystolic, toprol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nebivolol

Arm Type

Active Comparator

Arm Title

Metoprolol Succinate

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Nebivolol

Other Intervention Name(s)

Bystolic

Intervention Description

Subject will take nebivolol daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Metoprolol succinate

Other Intervention Name(s)

Toprol XL

Intervention Description

Subject will take metoprolol succinate daily for 12 weeks.

Primary Outcome Measure Information:

Title

Quality of Life

Description

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)

Secondary Outcome Measure Information:

Title

Blood Pressure

Description

Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Gabardi, PharmD, FCCP, BCPS

Organizational Affiliation

Transplant Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Lahey Clinic

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

12. IPD Sharing Statement

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The Impact of Nebivolol Versus Metoprolol on Quality of Life

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