Impact of Catecholamine Spill-over on Outcome After RDN and EP Ablation

Impact of Patient-specific and Procedural Characteristics Like Catecholamine Spill-over on the Long-term Outcome After Renal Denervation and EP Ablation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01875809

Acronym

RDN-Cath-1

Enrollment

Registered

2013-06-12

Start date

2013-03-31

Completion date

Unknown

Last updated

2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

RDN, renal denervation, catecholamine, spill-over, blood pressure, electrophysiology, ablation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* medically-indicated renal denervation * Age over 18 years * written informed consent

Exclusion criteria

* pregnancy * expected compliance problems * current participation in other studies

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Contacts

Primary ContactKlaus A Tiroch, MD

klaus.tiroch@helios-kliniken.de+49-202-896-5698

Backup ContactJacek Szymanski, MD

jacek.szymanski@helios-kliniken.de+49-202-896-5377

Outcome results