Hypertension in Hemodialysis Patients (Aim 3) - Full Text View

Sponsor:	Indiana University
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00582114

Purpose

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.

Condition	Intervention	Phase
Hemodialysis Hypertension Left Ventricular Hypertrophy	Drug: Lisinopril Drug: Atenolol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hypertension in Hemodialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis High Blood Pressure

Drug Information available for: Atenolol Lisinopril

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	August 2005
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Atenolol	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
Experimental: 2 Lisinopril	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.

Arms

Assigned Interventions

Active Comparator: 1

Atenolol

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

Experimental: 2

Lisinopril

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.

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 ACE inhibitor (lisinopril) vs. beta-blocker therapy (atenolol) each administered three times weekly after dialysis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients on chronic hemodialysis for > 3 mos.
Compliance with hemodialysis treatments as defined by less than one missed dialysis per month
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.
Presence of LVH on echocardiogram defined as LVMi >104 g/m2 in women and >116 g/m2 in men.
Willingness to give informed consent.

Exclusion criteria:

Vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months
Noncompliance with hemodialysis treatments
Known drug abuse
COPD requiring home oxygen
Congestive Heart Failure Class III or IV.
Body mass index > 40 kg/m2.
Known contraindication to atenolol (severe heart failure, bradycardia, bronchial asthma, intolerance or allergy) or lisinopril (cough, pregnancy, intolerance or allergy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582114

Locations

United States, Indiana
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Rajiv Agarwal, MD 317-988-2241

Sponsors and Collaborators

Indiana University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Rajiv Agarwal, MD

Indiana University

More Information

No publications provided

Responsible Party:	Rajiv Agarwal, Indiana University
ClinicalTrials.gov Identifier:	NCT00582114 History of Changes
Other Study ID Numbers:	0306-13, R01DK062030, NIH-NIDDK-5RO1-062030
Study First Received:	December 20, 2007
Last Updated:	March 25, 2011
Health Authority:	United States: Federal Government

Keywords provided by Indiana University:

Hemodialysis
Hypertension
Left ventricular hypertrophy

Additional relevant MeSH terms:

Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Atenolol
Lisinopril
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents

Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012