Investigation of the Impact of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Serum B-type Natriuretic Peptide (BNP) Level of Diabetic Patients With Congestive Heart Failure.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Serum BNP level with and without DPP-4 inhibitor use.
研究概览
简要总结
We thought to investigate the influence of DPP-4 inhibitor on the serum BNP level of diabetic patients with congestive heart failure. This study consists of two protocols. In the first protocol, diabetic patients with high level of serum BNP (100-2000 pg/ml) receiving outpatient treatment with any type of DPP-4 inhibitor at our institution will be enrolled. After baseline data collection, DPP-4 inhibitor will be suspended for one month and serum BNP will be measured. The DPP-4 inhibitor will be resumed and after another month, serum BNP will be measured again. In the other protocol, diabetic patients who were hospitalized due to heart failure were enrolled. DPP-4 inhibitor will be started (if the patient is not taking a DPP-4 inhibitor) or suspended (if the patient is taking a DPP-4 inhibitor) after stabilization of heart failure, and serum BNP will be measured before and after the drug administration or suspension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 diabetes patient with congestive heart failure under treatment with DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) .
- •High serum BNP (100-2000pg/ml).
- •Patients who have given informed consent to participation in the study.
排除标准
- •HbA1c over 9.0%.
- •Patients who changed medication within 1 months before inclusion.
- •Judged as ineligible by clinical investigators.
- •Hospitalization arm
- •Inclusion Criteria:
- •Type 2 diabetes patient who were hospitalized for congestive heart failure.
- •Patients who have given informed consent to participation in the study.
- •Exclusion Criteria:
- •Patients on insulin therapy.
- •Judged as ineligible by clinical investigators.
研究组 & 干预措施
Outpatient arm
After baseline data collection, DPP-4 inhibitor will be suspended for one month and serum BNP will be measured. The DPP-4 inhibitor will be resumed and after another month, serum BNP will be measured again.
干预措施: Suspending DPP-4 inhibitor, in outpatient service (Drug)
Hospitalization arm 1
After hospitalization, medication for diabetes will be suspended. During the treatment for heart failure, drugs other than DPP-4 inhibitor will be resumed when required. After the stabilization of heart failure, DPP-4 inhibitor will be resumed (or administered if it was not prescribed before hospitalization) and serum BNP before and after the initiation of DPP-4 inhibitor will be measured.
干预措施: Starting DPP-4 inhibitor after treatment of heart failure (Drug)
Hospitalization arm 2
After hospitalization, medication for diabetes may be suspended or continued. During the treatment for heart failure, drugs including DPP-4 inhibitor will be resumed when required. After the stabilization of heart failure, DPP-4 inhibitor will be suspended and serum BNP before and after the suspension of DPP-4 inhibitor will be measured.
干预措施: Suspending DPP-4 inhibitor after treatment of heart failure (Drug)
结局指标
主要结局
Serum BNP level with and without DPP-4 inhibitor use.
时间窗: 3 days to 2 months
In the outpatient arm, changes in serum BNP level measured 1 month after suspension of DPP-4 inhibitor, and 1month after resumption of the DPP-4 inhibitor will be analyzed. In the hospitalization arm, serum BNP before and 2-3 days after the initiation of DPP-4 inhibitor will be measured and compared.
次要结局
- Heart failure hospitalization(2 months)
- Cardiovascular death(2 months)
- All cause mortality(2 months)
- Worsening heart failure(3 days)
- Echocardiographic measures (Changes in echocardiographic measures during the study period.)(3 days to 2 months)
- Other neurohormonal factors (Changes in plasma renin, aldosterone, serum stromal cell-derived factor 1 alpha, serum active glucagon-like peptide-1, serum active glucose-dependent insulinotropic polypeptid)(3 days to 2 months)