Therapy-resistant Hypertension and Sleep Apnea Clinical Trial
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
| Verified date | October 2017 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 2017 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Division of Cardiology | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 and 12 months | |
| Secondary | 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 | 1, 3, 6 12 months | |
| Secondary | 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 | 1, 3, 6, 12 | |
| Secondary | 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 | ||
| Secondary | Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation | 6 and 12 months | ||
| Secondary | 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 | 1, 3, 6, and 12 months |