Trial · NCT00582114

Hypertension in Hemodialysis Patients (Aim 3)

NCT00582114, Phase 3, Terminated, Indiana University; results first posted 2016-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hypertension in Hemodialysis Patients (Aim 3). Trials, record NCT00582114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00582114

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Hypertension in Hemodialysis Patients (Aim 3)
NCT number: NCT00582114
Status: Terminated
Phases: Phase 3
Enrollment: 200 participants, actual
Lead sponsor: Indiana University
Conditions: Hemodialysis, Hypertension, Left Ventricular Hypertrophy
Interventions: Lisinopril, Atenolol
First posted: 2007-12-28
Last updated: 2016-01-18
Results first posted: 2016-01-18

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.	Baseline, 6 months, 12 months	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.
Other	Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	1 yr	Cardiovascular events were counted by subject and included the following: myocardial infarction (MI), stroke, hospitalization for congestive heart failure (CHF), hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. Adverse events reported are those during the course of 12 months of participation in the trial. All serious adverse events were adjudicated by R.A. and A.D.S. who were masked to the drug assignment at the time of adjudication. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. The cardiovascular event rate was calculated by treatment group assignment. Incidence rate ratio (IRR) by treatment was then determined along with the 95% confidence intervals (95% CIs). As a post hoc analysis, we also determined the narrower definition of cardiovascular events per group that included MI, stroke, CHF, or cardiovascular death.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.	Baseline, 6 months, 12 months	The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. The analysis was performed by intention to treat, if the patient received at least one dose of the randomized drug regardless of the availability of a post-baseline echocardiogram.	g/m^2	MEAN
OTHER_PRE_SPECIFIED	Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	1 yr		events/100 patient-years	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.	Atenolol	LVMI Change from baseline, 6 months	-8.4	Standard Deviation 5.1	g/m^2
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.	Lisinopril	LVMI Change from baseline, 6 months	-3.4	Standard Deviation 5.5	g/m^2
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.	Atenolol	LVMI Change from baseline, 12 months	-21.5	Standard Deviation 5.7	g/m^2
The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.	Lisinopril	LVMI Change from baseline, 12 months	-15.1	Standard Deviation 6.2	g/m^2
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	Atenolol	Incidence rate, cardiovasular events	24.6		events/100 patient-years
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	Lisinopril	Incidence rate, cardiovasular events	58		events/100 patient-years
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	Atenolol	Incidence rate, combined MI, stroke, CHF, CV death	13.5		events/100 patient-years
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	Lisinopril	Incidence rate, combined MI, stroke, CHF, CV death	31		events/100 patient-years
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	Atenolol	Incidence rate, congest heart failure	6.2		events/100 patient-years
Serious Adverse Events and Cardiovascular Events That Led to Trial Termination	Lisinopril	Incidence rate, congest heart failure	20.2		events/100 patient-years

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Atenolol	100
Overall Study	STARTED	Lisinopril	100
Overall Study	COMPLETED	Atenolol	58
Overall Study	COMPLETED	Lisinopril	46
Overall Study	NOT COMPLETED	Atenolol	42
Overall Study	NOT COMPLETED	Lisinopril	54

Source ClinicalTrials.gov

Adverse events74

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	Atenolol	20	100	25
other	Fatigue	General disorders	Lisinopril	6	100	12
other	Gastrointestinal disorders	Gastrointestinal disorders	Atenolol	5	100	6
other	Gastrointestinal disorders	Gastrointestinal disorders	Lisinopril	6	100	6
other	Upper respiratory infection	Infections and infestations	Atenolol	1	100	1
other	Upper respiratory infection	Infections and infestations	Lisinopril	2	100	4
other	bradycardia	General disorders	Atenolol	2	100	3
other	bradycardia	General disorders	Lisinopril	1	100	1
other	Intradialytic hypotension	General disorders	Atenolol	6	100	7
other	Intradialytic hypotension	General disorders	Lisinopril	4	100	4

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atenolol
Total, all-cause mortality	Lisinopril
Total, other adverse events	Atenolol	44	100
Total, other adverse events	Lisinopril	29	100
Total, serious adverse events	Atenolol	58	100
Total, serious adverse events	Lisinopril	70	100

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24398888	DERIVED	PubMed
37651553	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK062030	Hypertension in Hemodialysis Patients	AGARWAL, RAJIV	INDIANA UNIVERSITY INDIANAPOLIS	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2003 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Atenolol vs Lisinopril: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00582114

GET https://conductscience.org/api/trials/v1/NCT00582114/events?page=2

API reference For AI assistants