Autonomic and cardiac function in end stage renal disease patients: A pilot study

Withdrawn

Conditions: autonomic function
heart function
10019280
10038430
10003184

Registration Number: NL-OMON37476

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

All patients with chronic kidney disease (CKD) stage five who are in a pre-dialysis course and planned for an AVF construction are included in the intervention group.

Exclusion Criteria

1. chronic atrial fibrillation or
2. frequent ventricular premature beats,
3. grade III or IV heart failure (according to the NYHA),
4. with permanent pacemakers,
5. previous vascular access (AVF, graft or venous-catheter) or PD catheter,
6. impaired mental capacity or language barrier.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Autonomic function<br /><br>o The following measurements are made in rest:<br /><br>o heart rate variability (HRV),<br /><br>o blood pressure variability (BPV) and<br /><br>o baroreflex sensitivity (BRS).<br /><br>o Respiratory sinus arrhythmia (RSA) is determined during the deep breathing<br /><br>test.<br /><br>o During the vasalva manoeuvre the following measurements are made:<br /><br>o vasalva ratio (VR) and<br /><br>o blood pressure respons to the vasalva manoeuvre.<br /><br>o Blood pressure and heart rate response to the supine-to-stand-test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Cardiac function measured using echocardiography<br /><br>- Blood serum levels of several heart markers<br /><br>- Score on the Hand Ischemic Questionnaire (HIQ).<br /><br>- Score on the Minnesota living with heart failure questionnaire (Minnesota).<br /><br>- Successful AVF maturation<br /><br>- Mortality<br /><br>- Morbidity</p><br>