Hypertension in Hemodialysis | Clinical Trial

Key information

Conditions

Hypertension Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Left Ventricular Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Affiliated Dialysis Unit

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Adults with hypertension on hemodialysis Hypertensive, long-term (3 months or more) hemodialysis patients will be studied over a 6 hemodialysis baseline phase during which 44-hour interdialytic ambulatory BP will be performed and baseline symptoms collected. Patients with well-controlled hypertension, on anti-hypertensive therapy will have blood pressure medications withdrawn until they become hypertensive as assessed by 44-hour interdialytic ambulatory blood pressure recording. We will exclude patients who have had vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months, ambulatory BP >170 mm Hg systolic or >100 mm Hg diastolic, those who miss 2 or more hemodialysis treatments in the previous month, abuse street-drugs, require home oxygen, have symptomatic congestive heart failure or are morbidly obese (body mass index > 40 kg/m2).

Treatment and study plan

Ultrafiltration

Other

All patients participating in the trial require evaluation of dry-weight at each dialysis visit for evaluation. An initial weight loss of 0.1kg/10 kg body-weight will be prescribed per dialysis. If ultrafiltration is not tolerated based on muscle cramps, need for excessive saline or symptomatic hypotension, the intensity of ultrafiltration will be reduced by 50%. If ultrafiltration is still not tolerated, the weight loss will be further reduced by 50%. If the patient cannot tolerate at least 0.2 kg incremental weight loss per dialysis, the patient will be said to be at goal dry-weight. Thus, by this protocol, all patients must experience symptoms of volume depletion to be at dry weight.

Primary outcomes

The primary outcome parameter will be systolic reduction in 44h-interdialytic ambulatory BP with ultrafiltration as compared to the control group by intention to treat analysis

Time frame: 0, 4, 8 wks

Secondary outcomes

Per protocol analysis of primary outcome with 1. weight loss as the covariate. 2. baseline left-atrial size and weight loss as covariates.3. Others: (Description restricted by space limitation)

Time frame: 0, 4, 8 wks

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

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

Registry information

Important dates

Study start: 2003
Primary completion: 2008
Study completion: 2008
First posted: Aug 27, 2003
Registry last updated: Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed