Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure
Condition: Peripheral Artery Disease; Hypertension
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: nebivolol; Metoprolol succinate
Intervention description: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing).; Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 0.6-0.9. 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.

        Exclusion Criteria:

          -  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