NCT04646902进行中（未招募）不适用
Relevance of the Ratio Kynurenine/Tryptophan to Characterize Hypertension Associated to Obstructive Sleep Apnea (KYNTOSA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 203
- 试验地点
- 5
- 主要终点
- Kynurenine / Tryptophan ratio
研究概览
简要总结
Obstructive Sleep Apnea (OSA) is an independent risk factor for hypertension (HTN) and the most common cause of resistant HTN. The mechanisms underlying OSA-associated HTN are not completely understood. This is crucial to find novel therapeutic targets of OSA-associated HTN. The Aryl Hydrocarbon Receptor (AHR) is a cytosolic transcription factor that has been linked with the pathogenesis of HTN.
This study aims to evaluate the role of endogenous ligands of AHR such as kynurenine in discriminating patients with OSA-associated HTN. For that aim, a case-control study will be performed in patients with and without hypertension exposed and not exposed to OSA. Kynurenine and other metabolites will be quantified in urine and serum samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 30 years old attending the outpatient clinics of the clinical sites.
- •Diagnosis of hypertension defined either as: a) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or b) in untreated patients: office systolic blood pressure values >= 140 mmHg and/ or diastolic blood pressure values >= 90 mmHg.
- •Able to understand and communicate effectively with study personnel.
- •Giving written informed consent to participate.
排除标准
- •Self-reported pregnancy or breastfeeding.
- •Patients on haemodialysis or peritoneal dialysis.
- •Chronic liver disease with Child-Pugh score B or higher.
- •Hypertension attributed to renal artery stenosis, primary hyperaldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of aorta.
- •History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.
- •Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.
- •Pulmonary hypertension.
- •Current diagnosed oncological disease.
- •Patients with known chronic or acute infectious diseases.
- •Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study
- •CONTROLS (individuals without hypertension with and without OSA) For each case, an age and gender-matched control will be selected.
- •Exclusion Criteria:
- •Pregnancy or breastfeeding.
- •Patients on haemodialysis or peritoneal dialysis.
- •Chronic liver disease with Child-Pugh score b or higher.
- •History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.
- •Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.
- •Pulmonary hypertension.
- •Current diagnosed oncological disease.
- •Patients with known chronic or acute infectious diseases.
- •Patients with known chronic or acute infectious diseases.
- •Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study.
结局指标
主要结局
Kynurenine / Tryptophan ratio
时间窗: Day 1 (visit 1)
Ratio between kynurenine and tryptophan concentrations
次要结局
- Concentrations of metabolites(Day 1 (visit 1))
研究者
研究点 (5)
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