Hypertension, Resistant to Conventional TherapyNCT02559882
How to Test Success of a Renal Denervation
An observational study of Hypertension, Resistant to Conventional Therapy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study aimed to assess the success of a clinically indicated renal denervation by different tests and correlate the results of the tests with the clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2015to 21 Dec 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with therapy resistant hypertension and clinical indication for renal nerve ablation
Who may be able to join
- Male and female patients 18 years to 85 years of age, with a diagnosis of re-sistant hypertension (office sitting blood pressure >140/90 mmHg and 24-hour blood pressure >130/80 mmHg in patients treated with at least three antihypertensive drugs including a diuretic) and a clinical indication for a renal denervation.
Who cannot join
- Secondary cause of hypertension
- Anatomical contraindication to renal denervation (renal artery diameter less than 4 mm or more than 8 mm), multiple renal artery, length to bifurcation less than 2 cm
- Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).
- Alcohol or drug abuse,
- Malignancy (unless healed or remission > 5 years)
- Pregnancy
- Know allergy to contrast medium
- Participation in another study within the last month
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology University Heart Center Zurich University Hospital
Zurich, 8091
About this study
Official title: Testing Effectiveness of Renal Denervation in Patients With Therapy-resistant Hypertension
The study aimed to assess the success of a clinically indicated renal denervation by different tests and correlate the results of the tests with the clinical outcome.
Read the detailed description
We aim to test the response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and after a clinical indicated renal denervation. Renal Denervation is not a study intervention
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B
Changes in blood pressure and heart rate, in renal artery diameter and flow during adenosine infusion before and 1 year after renal denervation
Measured: chronic
lood pressure (office and 24-hour blood pressure), laboratory parameter before and 12 months after catheter-based renal denrevation
Measured: chronic
Secondary outcomes (1)
Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based
Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based
Measured: chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Why it stopped: The Enterprise decided to stop the production of the catheter used for the clinical indicated renal denervation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabella Sudano, MD Phd, Principal investigator, University Heart Center Cardiology University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559882
- Sponsor's protocol ID
- EK2015_0045
- Status last verified
- Jan 2019
- First submitted
- 24 Aug 2015
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Effectiveness of Renal Denervation in Patients With Therapy-resistant Hypertension
- ClinicalTrials.gov ID
- NCT02559882
- Acronym / sponsor ID
- EK2015_0045
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Enterprise decided to stop the production of the catheter used for the clinical indicated renal denervation
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 25 Sep 2015 (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.
The study aimed to assess the success of a clinically indicated renal denervation by different tests and correlate the results of the tests with the clinical outcome.
Detailed description
We aim to test the response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and after a clinical indicated renal denervation. Renal Denervation is not a study intervention
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with therapy resistant hypertension and clinical indication for renal nerve ablation
Key inclusion criteria (1 listed)
- Male and female patients 18 years to 85 years of age, with a diagnosis of re-sistant hypertension (office sitting blood pressure >140/90 mmHg and 24-hour blood pressure >130/80 mmHg in patients treated with at least three antihypertensive drugs including a diuretic) and a clinical indication for a renal denervation.
Key exclusion criteria (8 listed)
- Secondary cause of hypertension
- Anatomical contraindication to renal denervation (renal artery diameter less than 4 mm or more than 8 mm), multiple renal artery, length to bifurcation less than 2 cm
- Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).
- Alcohol or drug abuse,
- Malignancy (unless healed or remission > 5 years)
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
Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B
Time frame: chronic
Changes in blood pressure and heart rate, in renal artery diameter and flow during adenosine infusion before and 1 year after renal denervation
lood pressure (office and 24-hour blood pressure), laboratory parameter before and 12 months after catheter-based renal denrevation
Time frame: chronic
1 secondary outcome
Blood pressure (office and 24-hour blood pressure), laboratory parameter before and 1, 3, 6 months after catheter-based
Time frame: chronic
Results and safety
The study was stopped early (reason given: The Enterprise decided to stop the production of the catheter used for the clinical indicated renal denervation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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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.
Isabella Sudano, MD Phd principal investigator
University Heart Center Cardiology University Hospital Zurich
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, Resistant to Conventional Therapy, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Jan 2019. 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 Switzerland. 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?
The study was stopped early (reason given: The Enterprise decided to stop the production of the catheter used for the clinical indicated renal denervation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to adenosine infusion, cold pressure test, flow mediated dilation of renal artery before and 1 year after renal denervation B (time frame: chronic). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2019.