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

NCT ID: NCT01875809

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal denervation (RDN)

Change of catecholamine spill-over during RDN

No interventions assigned to this group

Electrophysiology (EP) Ablation

Change of catecholamine spill-over during EP ablation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* expected compliance problems
* current participation in other studies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Witten/Herdecke

OTHER

Sponsor Role lead

Responsible Party

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Tiroch, Klaus

Privatdozent Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus A Tiroch, MD

Role: PRINCIPAL_INVESTIGATOR

University Wittn/Herdecke

Locations

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HELIOS Klinikum

Wuppertal, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Klaus A Tiroch, MD

Role: CONTACT

+49-202-896-5698

Jacek Szymanski, MD

Role: CONTACT

+49-202-896-5377

Facility Contacts

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Klaus A Tiroch, MD

Role: primary

+49-202-896-5698

Jacek Szymanski, MD

Role: backup

+49-202-896-5377

References

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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.

Reference Type BACKGROUND
PMID: 21403086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21093036 (View on PubMed)

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.

Reference Type RESULT
PMID: 19710497 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26603990 (View on PubMed)

Other Identifiers

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RDN-Cathecholamines-1

Identifier Type: -

Identifier Source: org_study_id

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