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Hypertension in Hemodialysis Patients (Aim 3)
This study is currently recruiting participants.
Study NCT00582114   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: December 20, 2007   Last Updated: March 2, 2010   History of Changes

December 20, 2007
March 2, 2010
August 2005
August 2013   (final data collection date for primary outcome measure)
The primary end point is the regression of LVH by echocardiographic criteria from baseline to 1 year. [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00582114 on ClinicalTrials.gov Archive Site
  • Regression of LVH at 6 months [ Time Frame: 6 months ] [ Designated as 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 ] [ Designated as safety issue: No ]
Same as current
 
Hypertension in Hemodialysis Patients (Aim 3)
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.

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.

Phase III
Interventional
Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment
  • Hemodialysis
  • Hypertension
  • Left Ventricular Hypertrophy
  • 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.
    Other Name: Atenolol
  • 1: Active Comparator
    Atenolol
    Intervention: Drug: Atenolol
  • 2: Experimental
    Lisinopril
    Intervention: Drug: Lisinopril
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
 
August 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
 
United States
 
NCT00582114
Rajiv Agarwal, Indiana University
0306-13, NIH-NIDDK-5RO1-062030
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
Principal Investigator: Rajiv Agarwal, MD Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP