Clinical trial NCT00582114: Hypertension in Hemodialysis Patients (Aim 3)
Official title: Hypertension in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hemodialysis
Hypertension
Left Ventricular Hypertrophy
Keywords: Hemodialysis
Hypertension
Left ventricular hypertrophy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-12-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

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)

Primary outcomes:
measure: The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
Other outcomes:
measure: Serious Adverse Events and Cardiovascular Events That Led to Trial Termination
timeFrame: 1 yr
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Rajiv Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal R, Sinha AD, Pappas MK, Abraham TN, Tegegne GG. Hypertension in hemodialysis patients treated with atenolol or lisinopril: a randomized controlled trial. Nephrol Dial Transplant. 2014 Mar;29(3):672-81. doi: 10.1093/ndt/gft515. Epub 2014 Jan 6.