HypertensionRDN-Cath-1NCT01875809
Impact of Catecholamine Spill-over on Outcome After RDN and EP Ablation
An observational study of Hypertension, run by University of Witten/Herdecke at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing renal denervation or EP Ablation with informed consent fulfilling all inclusion criteria and None of the exclusion criteria.
Who may be able to join
- medically-indicated renal denervation
- Age over 18 years
- written informed consent
Who cannot join
- pregnancy
- expected compliance problems
- current participation in other studies
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
HELIOS Klinikum
Wuppertal, North Rhine-Westphalia, 42117
Klaus A Tiroch, MD, +49-202-896-5698, klaus.tiroch@helios-kliniken.de
Jacek Szymanski, MD, +49-202-896-5377, jacek.szymanski@helios-kliniken.de
About this study
Official title: Impact of Patient-specific and Procedural Characteristics Like Catecholamine Spill-over on the Long-term Outcome After Renal Denervation and EP Ablation
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.
- Conditions
- Hypertension
- Keywords
- RDN, renal denervation, catecholamine, spill-over, blood pressure, electrophysiology, ablation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation (RDN) | Change of catecholamine spill-over during RDN | |
| Electrophysiology (EP) Ablation | Change of catecholamine spill-over during EP ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiroch, Klaus, University of Witten/Herdecke
- Investigators
- Klaus A Tiroch, MD, Principal investigator, University Wittn/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875809
- Sponsor's protocol ID
- RDN-Cathecholamines-1
- Acronym
- RDN-Cath-1
- Status last verified
- Jun 2013
- First submitted
- 30 May 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21403086Symplicity 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.
PubMed 21093036Schlaich 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.
PubMed 19710497Tiroch 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.
PubMed 26603990
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient-specific and Procedural Characteristics Like Catecholamine Spill-over on the Long-term Outcome After Renal Denervation and EP Ablation
- ClinicalTrials.gov ID
- NCT01875809
- Acronym / sponsor ID
- RDN-Cath-1 / RDN-Cathecholamines-1
- Conditions
- Hypertension
- Keywords
- RDN, renal denervation, catecholamine, spill-over, blood pressure, electrophysiology, ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation (RDN) | – | –Change of catecholamine spill-over during RDN |
| Electrophysiology (EP) Ablation | – | –Change of catecholamine spill-over during EP ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing renal denervation or EP Ablation with informed consent fulfilling all inclusion criteria and None of the exclusion criteria.
Key inclusion criteria (3 listed)
- medically-indicated renal denervation
- Age over 18 years
- written informed consent
Key exclusion criteria (3 listed)
- pregnancy
- expected compliance problems
- current participation in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Catecholamine norepinephrine and epinephrine (pg/ml)
Time frame: 2 years
Measurement the differences of norepinephrine and epinephrine (pg/ml) in the renal vein and artery before and after the ablation
1 secondary outcome
Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Background: PubMed 21403086Symplicity 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.
- Background: PubMed 21093036Symplicity 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.
- Results publication: PubMed 19710497Schlaich 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.
- Derived from this study: PubMed 26603990Tiroch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus A Tiroch, MD principal investigator
University Wittn/Herdecke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of Witten/Herdecke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus A Tiroch, MD (+49-202-896-5698, klaus.tiroch@helios-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catecholamine norepinephrine and epinephrine (pg/ml) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875809, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.