The Impact of Nebivolol Versus Metoprolol on Quality of Life

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01441570
• Other study ID #: 2011P001638
• Status: Terminated
• Phase: N/A
• First received: September 26, 2011
• Last updated: July 15, 2013
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hypertension
• Renal Insufficiency
• Transplant; Failure, Kidney

Intervention

Drug:
• Nebivolol
Subject will take nebivolol daily for 12 weeks.
• Metoprolol succinate
Subject will take metoprolol succinate daily for 12 weeks.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Forest Laboratories, Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	Blood Pressure	Evaluate the number of subjects in the nebivolol group that are at goal blood pressure (120/80 mmHg) as compared to those in the metoprolol succinate group.	12 weeks	No
Secondary	Cost-effectiveness	Evaluate the cost-effectiveness of nebivolol as compared to metoprolol succinate.	12 weeks	No
Secondary	Urine Protein and calculated GFR	Evaluate change in urinary protein excretion and calculated glomerular filtration rate in subjects in the nebivolol group as compared with those in the metoprolol succinate group.	12 weeks	No