Effect of Nebivolol Compared With Metoprolol in Hypertensive Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Peak Walking Time (PWT)
研究概览
简要总结
This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an active control, metoprolol succinate, in patients with established lower-extremity peripheral artery disease, hypertension, and at least moderate risk for coronary artery disease.
详细描述
Peripheral arterial disease (PAD) affects up to an estimated 16-29% of men and women over age 50, and is associated with increased cardiovascular morbidity and mortality. Beta-blockers have been shown to reduce the risk of myocardial infarction and death in patients with coronary artery disease (CAD) and are indicated for the treatment of hypertension in patients with PAD. However, there is a theoretical risk that antihypertensive therapy may decrease limb perfusion pressure and therefore exacerbate symptoms of claudication or limb ischemia. Patients with CAD and concomitant PAD are less likely to be prescribed beta-blockers, even though most patients are able to tolerate antihypertensive therapy without worsening of symptoms.
The third generation beta-blocker, nebivolol, has vasodilating properties in addition to beta-adrenergic blockade. This vasodilatory effect is mediated through the L-arginine-nitric oxide-dependent pathway. Nitric oxide is a critical modulator of vascular disease with effects that lead to vasodilatation, endothelial regeneration, inhibition of leukocyte chemotaxis and inhibition of platelet adhesion. This combination of beta-blockade and nitric oxide-dependent vasodilation may enhance effectiveness and tolerability of nebivolol versus other beta-blockers in patients with hypertension, CAD or high-risk state, and PAD.
This study will be a pilot comparative effectiveness study to examine the effect of nebivolol versus metoprolol succinate in patients with lower-extremity PAD and at least moderate risk for CAD on PAD symptoms as measured by both functional and quality of life measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and non-pregnant, non-lactating women 45 years of age or older
- •Able to give informed consent and complete scheduled visits
- •Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.
- •If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment.
- •History of hypertension. Blood pressure at the screening visit must be ≤160/100 mmHg and ≥100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be ≤140/90 mmHg. In addition, heart rate must be ≥55 beats per minute if currently prescribed a beta-blocker and ≤60 beats per minute if not currently prescribed a beta-blocker.
- •At least moderate risk for CAD.
排除标准
- •Participation in another clinical trial
- •Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating <0.6 indicating disease potentially requiring revascularization
- •History of limb or digit amputation due to arterial insufficiency
- •Revascularization of peripheral vessels within the preceding 6 months
- •Uncontrolled hypertension as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
- •Contraindication or allergy to beta blocker therapy
- •History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months
- •Class III or IV angina
- •Current or past history of New York Heart Association (NYHA) class III or IV heart failure
- •Inability to walk on a treadmill for any reason
- •Regular use of nitroglycerin or nitrates including oral, transdermal ointment or patch, or sublingual, translingual spray and/or combination agents containing nitrates
- •Active liver, pulmonary, infectious or inflammatory process
- •History of malignancy within preceding 5 years (excluding basal or squamous cell skin cancer)
- •History of any other condition that, in the opinion of the investigators, renders it unsafe for the subject to be enrolled
研究组 & 干预措施
nebivolol
nebivolol 1 to 4 capsules daily
干预措施: nebivolol (Drug)
metoprolol succinate
metoprolol 1 to 4 capsules daily
干预措施: Metoprolol succinate (Drug)
结局指标
主要结局
Peak Walking Time (PWT)
时间窗: Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks.
Change in peak walking time (PWT) is measured in seconds. The PWT is defined as when walking on a treadmill cannot continue due to maximal leg pain, resulting in the discontinuation of the treadmill test.
次要结局
- Ankle-brachial Index (ABI)(Baseline ABI is measured at the time of enrollment and again at the final study visit at 26 weeks)
- Claudication Onset Time (COT)(Baseline COT is measured at the time of enrollment and again at the final study visit at 26 weeks.)
- Walking Impairment Questionnaire (WIQ) - Change Calf Pain(Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.)
- Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain(Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.)
- Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score(Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.)
- Walking Impairment Questionnaire (WIQ) - Change in WIQ Speed Score(Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.)
- Walking Impairment Questionnaire (WIQ) - Change in WIQ Stairs Score(Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.)