Therapy-resistant Hypertension and Sleep ApneaNCT01879566
Effect of Catheter-based Radiofrequency Ablation Therapy in Patient With Therapy-resistant Hypertension and Sleep Apnea Syndrome
An observational study of Therapy-resistant Hypertension and Sleep Apnea, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this prospective single-center study is to evaluate sympathetic nervous system directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome (defined by a complaint of excessive daytime… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Therapy-resistant Hypertension and Sleep Apnea
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Jul 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with therapy-resistant arterial hypertension and sleep apnea syndrome
Inclusion criteria: We plan to include male or female subjects, age 18-80 with a diagnosis of medium-severe sleep apnea syndrome (defined by symptoms, a complaint of excessive daytime sleepiness, an Epworth sleepiness score >8, and an apnea / hypopnea index >15/h) and a resistant hypertension (systolic blood pressure >140 mmHg or >130 mmHg in patients with type II diabetes or chronic kidney disease, under treatment with three antihypertensive drugs including a diuretic).
If the selected patients are treated with CPAP, this therapy should be stable during the whole study time.
Every patient will be asked for a written informed consent.
Exclusion criteria: - Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).
- Long acting nitrates, or PDE-5-Hemmer
- Alcohol or drug abuse,
- Malignancy (unless healed or remission > 5 years)
- Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- Pulmonary Hypertension (PAP>50 mmHg)
- Pregnancy
- Anatomical contraindication to renal denervation
- Know allergy to contrast
- Participation in another study within the last month
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, 8091
About this study
Official title: Effect of Catheter-based Radiofrequency Ablation Therapy of the Renal Sympathetic-Nerve System for Patient With Sleep Apnea Syndrome and Therapy Resistant Hypertension
The aim of this prospective single-center study is to evaluate sympathetic nervous system directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness score>8[10], and an apnea/hypopnea index (AHI>15/h) before and after catheter-based radiofrequency ablation of renal nerve. If the selected patients are treated with CPAP, this therapy should be stable during the whole study time. Primary and secondary end-point will be measured before and 1, 3, 6 and 12 months after renal sympathetic denervation.
- Being tested
- No intervention will be done. The study is observational
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be done. The study is observationalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation
The primary objective of this study is to evaluate sympathetic nervous system activity in patients with sleep apnea syndrome before and 6 and 12 months after catheter-based radiofrequency ablation therapy of the renal sympathetic-nerve system
Measured: 6 and 12 months
Secondary outcomes (5)
Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation
Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation
Measured: 1, 3, 6 12 months
Change in renal function (creatinin plasma level and GFR CKD-EPI Formula) before and after catheter-based renal denervation
Change in creatinin plasma level and GFR CKD-EPI Formula before and after catheter-based renal denervation
Measured: 1, 3, 6, 12
Change in sleep quality, pulse-oximetry, AHI, quality of life and subjective sleepiness with the Epworth sleepiness score before after catheter-based renal denervation
Measured: 1, 3, 6 and 12 months
Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation
Measured: 6 and 12 months
Change in vascular function and oxidative stress and inflammation parameters before and after catheter-based renal denervation
Change in vascular function (endothelial function as flow mediated dilatation, arterial stiffness by pulse wave velocity) and oxidative stress and inflammation parameters before and after catheter-based renal denervation
Measured: 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy-resistant Hypertension and Sleep ApneaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Luescher, Professor, MD, Principal investigator, University Hospital Zurich, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879566
- Sponsor's protocol ID
- EK2012_0393
- Status last verified
- Oct 2017
- First submitted
- 26 Apr 2013
- Last updated
- 25 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Catheter-based Radiofrequency Ablation Therapy of the Renal Sympathetic-Nerve System for Patient With Sleep Apnea Syndrome and Therapy Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01879566
- Acronym / sponsor ID
- EK2012_0393
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 18 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.
The aim of this prospective single-center study is to evaluate sympathetic nervous system directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness score>8[10], and an apnea/hypopnea index (AHI>15/h) before and after catheter-based radiofrequency ablation of renal nerve. If the selected patients are treated with CPAP, this therapy should be stable during the whole study time. Primary and secondary end-point will be measured before and 1, 3, 6 and 12 months after renal sympathetic denervation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with therapy-resistant arterial hypertension and sleep apnea syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be done. The study is observational | Other | – |
Primary outcome
Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation
Time frame: 6 and 12 months
The primary objective of this study is to evaluate sympathetic nervous system activity in patients with sleep apnea syndrome before and 6 and 12 months after catheter-based radiofrequency ablation therapy of the renal sympathetic-nerve system
5 secondary outcomes
Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation
Time frame: 1, 3, 6 12 months
Change in renal function (creatinin plasma level and GFR CKD-EPI Formula) before and after catheter-based renal denervation
Time frame: 1, 3, 6, 12
Change in sleep quality, pulse-oximetry, AHI, quality of life and subjective sleepiness with the Epworth sleepiness score before after catheter-based renal denervation
Time frame: 1, 3, 6 and 12 months
Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation
Time frame: 6 and 12 months
Change in vascular function and oxidative stress and inflammation parameters before and after catheter-based renal denervation
Time frame: 1, 3, 6, and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
Related trials for Therapy-resistant Hypertension and Sleep Apnea
Recruiting
Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension
Hypertension, Resistant to Conventional Therapy, Sleep Apnea
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.
Thomas Luescher, Professor, MD principal investigator
University Hospital Zurich, Division of Cardiology
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 Therapy-resistant Hypertension and Sleep Apnea, 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?
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: withdrawn, as of the sponsor's last update on 25 Oct 2017. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation (time frame: 6 and 12 months). 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 25 Oct 2017.