Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00999102
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2009-10-20
Brief Title:
Nebivolol Versus Metoprolol Comparative Effects on Fatigue and Quality of Life
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Nebivolol Vs Metoprolol Comparative Effects on Fatigue and Quality of Life
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Beta-blockers are prescribed to millions of people for treatment of hypertension Fatigue is a recognized and common side effect of beta-blockers that can have significant effects on quality of life Worse many people taking a beta-blocker for years are not even aware of the reduction of energy with which they are living
A new vasodilating beta-blocker nebivolol which is approved by the FDA for treatment of hypertension appears to be far less associated with fatigue than are most currently available beta-blockers The purpose of this study is to compare nebivolol with the current best-selling beta-blocker metoprolol and determine whether there is a significant difference in side effects including fatigue reduced exertion tolerance and reduced quality of life
In this study 30 subjects will take each of the 2 study drugs for 8 weeks consisting of 4 weeks at a lower dose and 4 weeks at a higher dose All dosages are FDA-approved for treatment of hypertension Subjects and investigators will not know which drug is being administered until completion of the study Subjects will undergo a treadmill stress test and will complete fatigue and quality of life questionnaires after each 4 weeks of treatment An echocardiogram and non-invasive measurement of aortic blood pressure will be performed after 8 weeks on each drug Also blood will be drawn and stored for possible measurement of drug levels after 4 and 8 weeks on each drug Results on each drug will then be compared If nebivolol is found to cause significantly less fatigue it would be of substantial importance to the many millions of people who are on life-long beta-blocker therapy and are living with reduced energy
A new vasodilating beta-blocker nebivolol which is approved by the FDA for treatment of hypertension appears to be far less associated with fatigue than are most currently available beta-blockers The purpose of this study is to compare nebivolol with the current best-selling beta-blocker metoprolol and determine whether there is a significant difference in side effects including fatigue reduced exertion tolerance and reduced quality of life
In this study 30 subjects will take each of the 2 study drugs for 8 weeks consisting of 4 weeks at a lower dose and 4 weeks at a higher dose All dosages are FDA-approved for treatment of hypertension Subjects and investigators will not know which drug is being administered until completion of the study Subjects will undergo a treadmill stress test and will complete fatigue and quality of life questionnaires after each 4 weeks of treatment An echocardiogram and non-invasive measurement of aortic blood pressure will be performed after 8 weeks on each drug Also blood will be drawn and stored for possible measurement of drug levels after 4 and 8 weeks on each drug Results on each drug will then be compared If nebivolol is found to cause significantly less fatigue it would be of substantial importance to the many millions of people who are on life-long beta-blocker therapy and are living with reduced energy
Detailed Description:
Hypothesis the beta-blocker nebivolol is associated with less fatigue than metoprolol the most widely-prescribed beta-blocker
Methods a double-blinded crossover trial comparing nebivolol with metoprolol Experimental procedures Subjects will undergo electrocardiogram and routine blood testing unless such tests have been performed within 6 months and are available for review Subjects entered into the study will receive each of the two study drugs for 8 weeks Metoprolol succinate will be given at a dose of 50 mg daily for 4 weeks then 100 mg daily for 4 weeks For nebivolol dosage will be 5 mg daily for 4 weeks and 10mg daily for 4 weeks Identical-appearing pills will be given and the drugs will be given in randomized order without a placebo run-in period
At the end of each 4-week treatment period on each drug subjects will undergo a treadmill stress test using the standard Cornell protocol complete Quality of Life and fatigue questionnaires and have blood drawn and frozen for later analysis for drug levels
At the end of 8 weeks of treatment on each drug subjects will undergo echocardiography and applanation tonometry non-invasive measurement of aortic blood pressure to assess heart function
At the end of the study the blinded subjects will be asked which of the two study drugs they preferred and the extent to which their energy differed between the two drugs
-Rationale Millions of hypertensive patients are on life-long beta-blocker therapy In many it reduces cardiac output and increases peripheral resistance to blood flow 1 It is well-established that beta-blockers cause fatigue in many patients and reduce exertion tolerance Every physician knows this and tacitly accepts that many patients are living with this unwelcome side effect
A new beta-blocker nebivolol has the standard beta-blocking effects but also produces blood vessel relaxation vasodilation probably through increased secretion of the vasodilator nitric oxide Studies indicate that nebivolol unlike most beta-blockers does not cause constriction of peripheral blood vessels and is associated with improved heart function 2 Studies suggest that it is also less likely to cause fatigue 3
Personal experience is consistent with this as I have observed marked improvement in energy in patients in whom I have prescribed nebivolol in place of a different beta-blocker The possibility of placebo effect of course cannot be excluded Nevertheless the known hemodynamic differences between nebivolol and other beta-blockers and the positive clinical experience warrant formal study to determine whether nebivolol is kinder than other beta-blockers in terms of the important side effect of fatigue
Methods a double-blinded crossover trial comparing nebivolol with metoprolol Experimental procedures Subjects will undergo electrocardiogram and routine blood testing unless such tests have been performed within 6 months and are available for review Subjects entered into the study will receive each of the two study drugs for 8 weeks Metoprolol succinate will be given at a dose of 50 mg daily for 4 weeks then 100 mg daily for 4 weeks For nebivolol dosage will be 5 mg daily for 4 weeks and 10mg daily for 4 weeks Identical-appearing pills will be given and the drugs will be given in randomized order without a placebo run-in period
At the end of each 4-week treatment period on each drug subjects will undergo a treadmill stress test using the standard Cornell protocol complete Quality of Life and fatigue questionnaires and have blood drawn and frozen for later analysis for drug levels
At the end of 8 weeks of treatment on each drug subjects will undergo echocardiography and applanation tonometry non-invasive measurement of aortic blood pressure to assess heart function
At the end of the study the blinded subjects will be asked which of the two study drugs they preferred and the extent to which their energy differed between the two drugs
-Rationale Millions of hypertensive patients are on life-long beta-blocker therapy In many it reduces cardiac output and increases peripheral resistance to blood flow 1 It is well-established that beta-blockers cause fatigue in many patients and reduce exertion tolerance Every physician knows this and tacitly accepts that many patients are living with this unwelcome side effect
A new beta-blocker nebivolol has the standard beta-blocking effects but also produces blood vessel relaxation vasodilation probably through increased secretion of the vasodilator nitric oxide Studies indicate that nebivolol unlike most beta-blockers does not cause constriction of peripheral blood vessels and is associated with improved heart function 2 Studies suggest that it is also less likely to cause fatigue 3
Personal experience is consistent with this as I have observed marked improvement in energy in patients in whom I have prescribed nebivolol in place of a different beta-blocker The possibility of placebo effect of course cannot be excluded Nevertheless the known hemodynamic differences between nebivolol and other beta-blockers and the positive clinical experience warrant formal study to determine whether nebivolol is kinder than other beta-blockers in terms of the important side effect of fatigue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None