Official Title: “Hypertension in Hemodialysis Patients”

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 LVH over one year in patients with hemodialysis hypertension despite similar degree of BP reduction.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2013

This is a parallel group, active control, single-center, open-label, randomized controlled trial comparing the safety and efficacy of initial therapy with an ACE inhibitor (lisinopril) vs. beta-blocker therapy (atenolol) each administered three times weekly after dialysis.

Intervention(s) in this Clinical Trial

• Drug: Lisinopril
  • Patients will be randomized into two groups, one that is beta blocker based, the other 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.
• Drug: Atenolol
  • Patients will be randomized into two groups, one that is beta blocker based, the other 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Atenolol
• Experimental: 2
  • Lisinopril

Primary Measures

• The primary end point is the regression of LVH by echocardiographic criteria from baseline to 1 year.
  • Time Frame: 1 yr
    Safety Issue?: No

Secondary Measures

• Regression of LVH at 6 months
  • Time Frame: 6 months
    Safety Issue?: No
• ITT average reduction in LVM indexed for body surface area from baseline to one year in two groups and adjusted for biologically important covariates, such as age, gender, and ambulatory BP.
  • Time Frame: 1 yr
    Safety Issue?: No

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 ABPM >135/75 mm Hg after participation in the UF Trial, or those on no antihypertensive medications but unwilling to do UF Trial.
• 4. Presence of LVH on echocardiogram defined as 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. 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

Rajiv Agarwal, MD Principal Investigator Indiana University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00582114

Study ID Number: 0306-13

ClinicalTrials.gov Identifier: NCT00582114

Health Authority: United States: Federal Government