Clinical Trials Logo
  1. Home
  2. Cardiovascular Disease
  3. NCT00925483
  4. Details
NCT00925483 Clinical Trial

Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Cardiovascular Disease Clinical Trial

Official title:
Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00925483
Other study ID # #04-050
Secondary ID
Status Recruiting
Phase N/A
First received June 19, 2009
Last updated February 24, 2010
Start date August 2004

Study information
Verified date February 2010
Source Dallas VA Medical Center
Contact Devasmita C. Dev, MD
Phone 214-857-1593
Email Devasmita.dev@med.va.gov
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Given the known increased risk of heart disease in hemodialysis patients, this study aims to evaluate the change in both size and function of the heart by using cardiac magnetic resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly), daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly) and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization. The patients are randomly put in the groups based on predetermined randomization schedule and the cardiologist trained in cardiac MRI readings is blinded to the patient treatment schedule. Given that changes in heart function may be seen with cardiac imaging techniques within 6 months, the expectation is that groups on daily treatment may have better outcome for this parameter as changes in volume and blood pressure may also be affected in a positive way in patients on daily dialysis.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- End stage renal disease patients on hemodialysis

Exclusion Criteria:

- Weight > 350 lbs

- Known poor dialysis and or treatment compliance

- Unable to come for daily treatments if randomization occurs in this group

- Prognosis less than 6 months

- Difficulty in tolerating dialysis and possibility of discontinuation of dialysis before 6 months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• dialysis
different dialysis schedules for each arm

Locations
Country Name City State
United States Dallas VA Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary LVM change per Cardiac MRI 6 months No
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Completed NCT02502812 - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects Phase 1
Recruiting NCT04216342 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers Phase 1
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT03646656 - Heart Health Buddies: Peer Support to Decrease CVD Risk N/A
Completed NCT02081066 - Identification of CETP as a Marker of Atherosclerosis N/A
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Recruiting NCT03095261 - Incentives in Cardiac Rehabilitation N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Completed NCT02711878 - Healing Hearts and Mending Minds in Older Adults Living With HIV N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Completed NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Completed NCT02868710 - Individual Variability to Aerobic Exercise Training N/A
Recruiting NCT02885792 - Coronary Artery Disease in Patients Suffering From Schizophrenia N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Completed NCT02657382 - Mental Stress Ischemia: Biofeedback Study N/A
Completed NCT02640859 - Investigation of Metabolic Risk in Korean Adults
Completed NCT02272946 - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk Phase 2
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment