NCT03050229已完成4 期
SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 12
- 主要终点
- Reduction of nocturnal blood pressure measured by ABPM
研究概览
简要总结
To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension
详细描述
The study consists of a 8-week run-in period and a 12-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following criteria at the start of treatment are eligible for the study:
- •Receiving stable treatment with anti-hypertensive including ARB for at least 8 weeks at baseline (0W).
- •Receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0W).
- •HbA1c>=6.0%, <10%
- •Seated office SBP 130-159mmHg or DBP 80-99mmHg
- •Nocturnal hypertension (SBP>=115 mmHg) as measured by Home BP during 5days before baseline (0W).
排除标准
- •Patients who meet any of the following criteria are not eligible for the study:
- •History of hypersensitivity to empagliflozin
- •Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
- •Treated with insulin or SU
- •With renal dysfunction (eGFR<45mL/min/1.73m2)
- •With liver dysfunction (AST or ALT is 3 times higher than reference value)
- •Hypotension (systolic blood pressure < 90 mmHg)
- •With pituitary gland dysfunction or adrenal gland dysfunction
- •Heart failure patients whose NYHA class is IV
- •Deemed ineligible for the study due to another reason by investigator
- •History of diabetic ketoacidosis or diabetic come within 3 months before enrollment
- •History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment
- •Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment
- •Patients received SGLT2 inhibitor within 8 weeks before enrollment
研究组 & 干预措施
Empagliflozin
Experimental
Empagliflozin 10mg/day is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
干预措施: Empagliflozin (Drug)
Placebo
Placebo Comparator
Placebo is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of nocturnal blood pressure measured by ABPM
时间窗: 12 weeks
次要结局
- Change in Sleep efficacy -Frequency of nocturnal awakening(12 weeks)
- Change in Sleep efficacy -Frequency of nocturia(12 weeks)
- Changes in the measures of circulating volume -Plasma NT-proBNP(12 weeks)
- Changes in the measures of circulating volume -ANP(12 weeks)
- Reduction of Blood pressure measured by ABPM -24h Blood Pressure(12 weeks)
- Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure(12 weeks)
- Reduction of Metabolism-related factors -HOMA-R(12 weeks)
- Reduction of Metabolism-related factors -HOMA-beta(12 weeks)
- Change in Sleep efficacy -Sleep scale (Athens insomnia scale)(12 weeks)
- Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure(12 weeks)
- Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability(12 weeks)
- Reduction of Metabolism-related factors -HbA1c(12 weeks)
- Reduction of Metabolism-related factors -body weight(12 weeks)
- Reduction of Metabolism-related factors -BMI(12 weeks)
- Reduction of Metabolism-related factors -lipids(12 weeks)
- Reduction of Metabolism-related factors -uric acid(12 weeks)
- Changes in the measures of organ damage -eGFR(12 weeks)
- The correlation between blood pressure and blood glucose control(12 weeks)
- Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio(12 weeks)
- The correlation between blood pressure and body weight(12 weeks)
- Changes in the measures of organ damage -Urinary Na/K(12 weeks)
- Changes in the measures of organ damage -cystatinC(12 weeks)
研究者
Kazuomi Kario
Professor & Chairman, Division of Cardiovascular Medicine, Department of Medicine
Jichi Medical University
研究点 (12)
Loading locations...
相似试验
已完成
不适用
SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertensioPatients with T2DM and nocturnal hypertensionJPRN-UMIN000024973Jichi Medical University School of Medicine176
终止
4 期
Dapagliflozin + Saxagliptin in a Basal-bolus Insulin TreatmentType 2 DiabetesNCT02965443University Hospital Tuebingen4
撤回
3 期
Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01984606Boehringer Ingelheim
终止
2 期
Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin LymphomaClassic Hodgkin LymphomaRelapsed Classical Hodgkin LymphomaRefractory Classic Hodgkin LymphomaHodgkin LymphomaNCT04788043Ranjana Advani8
撤回
2 期
Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With PrediabetesPostprandial HypoglycemiaNCT05174507University Hospital, Basel, Switzerland26