Hypertension in Hemodialysis Patients (Aim 3)
This study is ongoing, but not recruiting participants.
Sponsor:
Indiana University
Collaborator:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00582114
First received: December 20, 2007
Last updated: May 22, 2013
Last verified: May 2013
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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 3 |
| 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:
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.
|
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 More Information
No publications provided
| Responsible Party: | 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: | May 22, 2013 |
| 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 June 17, 2013