Therapy-resistant Hypertension and Sleep Apnea
Conditions
Brief 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 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.
Interventions
OTHERNo intervention will be done. The study is observational
Sponsors
University of Zurich
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation | 1, 3, 6 12 months | Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation |
| Change in renal function (creatinin plasma level and GFR CKD-EPI Formula) before and after catheter-based renal denervation | 1, 3, 6, 12 | Change in creatinin plasma level and GFR CKD-EPI Formula before and after catheter-based renal denervation |
| Change in sleep quality, pulse-oximetry, AHI, quality of life and subjective sleepiness with the Epworth sleepiness score before after catheter-based renal denervation | 1, 3, 6 and 12 months | — |
| Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation | 6 and 12 months | — |
| Change in vascular function and oxidative stress and inflammation parameters before and after catheter-based renal denervation | 1, 3, 6, and 12 months | 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 |
Countries
Switzerland
Outcome results
None listed