Hypertension in Hemodialysis Patients (Aim 3)

NCT00582114 | Terminated Phase 3 Results DMC

• 3 other identifiers: 0306-13R01DK062030NIH-NIDDK-5RO1-062030
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Hypertension; Left Ventricular Hypertrophy

Keywords

Hemodialysis; Hypertension; Left ventricular hypertrophy

Outcome Measures

Primary Outcomes (1)

• The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.

  The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.

  Baseline, 6 months, 12 months

Other Outcomes (1)

• Serious Adverse Events and Cardiovascular Events That Led to Trial Termination

  1 yr

Study Arms (2)

1

ACTIVE COMPARATOR

Atenolol

Drug: Atenolol

2

EXPERIMENTAL

Lisinopril

Drug: Lisinopril

Interventions

Lisinopril DRUG

Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (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.

2

Atenolol DRUG

Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• Presence of LVH on echocardiogram defined as left ventricular mass index (LVMi) \>104 g/m2 in women and \>116 g/m2 in men.
• Willingness to give informed consent.

You may not qualify if:

• Vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months
• Noncompliance with hemodialysis treatments
• Known drug abuse
• Chronic obstructive pulmonary disorder (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)

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

  PMID: 37651553 DERIVED

• 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.

  PMID: 24398888 DERIVED

MeSH Terms

Conditions

Hypertension; Hypertrophy, Left Ventricular

Interventions

Lisinopril; Atenolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cardiomegaly; Heart Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Dr. Rajiv Agarwal
• Organization: Professor of Medicine

ragarwal@iu.edu

317-988-2241

Study Officials

• Rajiv Agarwal, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 28, 2007
• Study Start: August 1, 2005
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 18, 2016
• Results First Posted: January 18, 2016

Record last verified: 2015-12

Locations

US (1)