Clinical trial NCT01875809: Impact of Catecholamine Spill-over on Outcome After RDN and EP Ablation
Official title: Impact of Patient-specific and Procedural Characteristics Like Catecholamine Spill-over on the Long-term Outcome After Renal Denervation and EP Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: RDN
renal denervation
catecholamine
spill-over
blood pressure
electrophysiology
ablation
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing renal denervation or EP Ablation with informed consent fulfilling all inclusion criteria and None of the exclusion criteria.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Catecholamine norepinephrine and epinephrine (pg/ml)
timeFrame: 2 years
Secondary outcomes:
measure: Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min)
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: HELIOS Klinikum
state: Nordrhein-Westfalen
Study officials:
affiliation: University Wittn/Herdecke
name: Klaus A Tiroch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011 May;57(5):911-7. doi: 10.1161/HYPERTENSIONAHA.110.163014. Epub 2011 Mar 14.
citation: Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
citation: Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009 Aug 27;361(9):932-4. doi: 10.1056/NEJMc0904179. No abstract available.
citation: Tiroch K, Sause A, Szymanski J, Nover I, Leischik R, Mann JF, Vorpahl M, Seyfarth M. Intraprocedural reduction of the veno-arterial norepinephrine gradient correlates with blood pressure response after renal denervation. EuroIntervention. 2015 Nov;11(7):824-34. doi: 10.4244/EIJV11I7A167.