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

Hypertension Clinical Trial

— RDN-Cath-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01875809
• Other study ID #: RDN-Cathecholamines-1
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2013
• Last updated: June 11, 2013
• Start date: March 2013

Study information

• Verified date: June 2013
• Source: University of Witten/Herdecke
• Contact: Klaus A Tiroch, MD
• Phone: +49-202-896-5698
• Email: klaus.tiroch[@]helios-kliniken.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• medically-indicated renal denervation

• Age over 18 years

• written informed consent

Exclusion Criteria:

• pregnancy

• expected compliance problems

• current participation in other studies

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Germany	HELIOS Klinikum	Wuppertal	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View Citation

Symplicity HTN-2 Investigators, Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Böhm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catecholamine norepinephrine and epinephrine (pg/ml)	Measurement the differences of norepinephrine and epinephrine (pg/ml) in the renal vein and artery before and after the ablation	2 years	No
Secondary	Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min)	Complete measurement of 24-hour systolic, diastolic, and mean arterial blood pressure (mmHg) and heart rate (beats/min)before and after ablation	2 years	No