Hypertension in Hemodialysis Patients (Aim 3)
Condition: Hemodialysis; Hypertension; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Intervention: Lisinopril; Atenolol
Intervention description: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.; Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
Intervention MeSH terms: Atenolol; Lisinopril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hypertension; Left ventricular hypertrophy

Summary:

      We will directly test the hypothesis that an initial strategy of lisinopril-based therapy
      will be more effective than atenolol-based therapy in causing regression of left ventricular
      hypertrophy (LVH) over one year in patients with hemodialysis hypertension despite similar
      degree of BP reduction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients on chronic hemodialysis for > 3 mos.

          2. Compliance with hemodialysis treatments as defined by less than one missed dialysis
             per month

          3. Hypertension as diagnosed by ambulatory blood pressure monitoring (ABPM) >135/75 mm Hg
             after participation in the ultrafiltration (UF) Trial, or those on no antihypertensive
             medications but unwilling to do UF Trial.

          4. Presence of LVH on echocardiogram defined as left ventricular mass index (LVMi) >104
             g/m2 in women and >116 g/m2 in men.

          5. Willingness to give informed consent.

        Exclusion criteria:

          1. Vascular event (stroke, myocardial infarction or limb ischemia requiring bypass)
             within previous six months

          2. Noncompliance with hemodialysis treatments

          3. Known drug abuse

          4. Chronic obstructive pulmonary disorder (COPD) requiring home oxygen

          5. Congestive Heart Failure Class III or IV.

          6. Body mass index > 40 kg/m2.

          7. Known contraindication to atenolol (severe heart failure, bradycardia, bronchial
             asthma, intolerance or allergy) or lisinopril (cough, pregnancy, intolerance or
             allergy)