NCT01875809

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

May 30, 2013

Last Update Submit

June 11, 2013

Conditions

Hypertension

Keywords

RDNrenal denervationcatecholaminespill-overblood pressureelectrophysiologyablation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min)

    2 years

Study Arms (2)

Renal denervation (RDN)

Change of catecholamine spill-over during RDN

Electrophysiology (EP) Ablation

Change of catecholamine spill-over during EP ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing renal denervation or EP Ablation with informed consent fulfilling all inclusion criteria and None of the exclusion criteria.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HELIOS Klinikum

Wuppertal, North Rhine-Westphalia, 42117, Germany

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21403086BACKGROUND

  • 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.

    PMID: 21093036BACKGROUND

  • 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.

    PMID: 19710497RESULT

  • 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.

    PMID: 26603990DERIVED

Biospecimen

Retention: NONE RETAINED

Blood for measurement of catecholamines.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Klaus A Tiroch, MD

    University Wittn/Herdecke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus A Tiroch, MD

CONTACT

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

Jacek Szymanski, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Privatdozent Dr. med.

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 12, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

DE(1)