Impact of Catecholamine Spill-over on Outcome After RDN and EP Ablation
- Conditions
- Hypertension
- Registration Number
- NCT01875809
- Lead Sponsor
- University of Witten/Herdecke
- Brief Summary
Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is known regarding the patient or procedural characteristics influencing the outcome. None of the detectable variables like number of ablation points, temperature rise, impedance drop, have been shown to correlate with the blood pressure (BP) reduction. In this study, the investigators assess different patient and procedural characteristics, like exact patient medication, stress hormones, heart rate variability, and focus on the change of the catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP ablation. The investigators hypothesize the correlation between reduction of catecholamine spill-over due to denervation and the BP reduction. In this study, the investigators will assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- medically-indicated renal denervation
- Age over 18 years
- written informed consent
- pregnancy
- expected compliance problems
- current participation in other studies
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Catecholamine norepinephrine and epinephrine (pg/ml) 2 years Measurement the differences of norepinephrine and epinephrine (pg/ml) in the renal vein and artery before and after the ablation
- Secondary Outcome Measures
Name Time Method Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min) 2 years Complete measurement of 24-hour systolic, diastolic, and mean arterial blood pressure (mmHg) and heart rate (beats/min)before and after ablation
Trial Locations
- Locations (1)
HELIOS Klinikum
🇩🇪Wuppertal, Nordrhein-Westfalen, Germany