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Impact of Catecholamine Spill-over on Outcome After RDN and EP Ablation (RDN-Cath-1)

U

University of Witten/Herdecke

Status

Unknown

Conditions

Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT01875809
RDN-Cathecholamines-1

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

80 participants in 2 patient groups

Renal denervation (RDN)
Description:
Change of catecholamine spill-over during RDN
Electrophysiology (EP) Ablation
Description:
Change of catecholamine spill-over during EP ablation

Trial contacts and locations

1

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Central trial contact

Klaus A Tiroch, MD; Jacek Szymanski, MD

Data sourced from clinicaltrials.gov

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