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| Name | Class |
|---|---|
| Mitsukoshi Health and Welfare Foundation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient arm | Experimental | 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. |
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| Hospitalization arm 1 | Experimental | 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. |
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| Hospitalization arm 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suspending DPP-4 inhibitor, in outpatient service | Drug | After baseline data collection, DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum BNP level with and without DPP-4 inhibitor use. | 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. | 3 days to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Any deaths during the study period. (only for the outpatient arm) | 2 months |
| Cardiovascular death | Any cardiovascular deaths during the study period. (only for the outpatient arm) |
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Outpatient arm
Inclusion Criteria:
Exclusion Criteria:
Hospitalization arm
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akihiro Isogawa, M.D. | Mitusui Memorial Hospital, Division of diabetes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mitsui Memorial Hospital | Taito-ku | Tokyo | Japan |
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| Starting DPP-4 inhibitor after treatment of heart failure | Drug | 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. |
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| Suspending DPP-4 inhibitor after treatment of heart failure | Drug | 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. |
|
| 2 months |
| Heart failure hospitalization | Any hospitalization due to worsening of heart failure during suspension of or within 1month after resumption of taking a DPP-4 inhibitor. (only for the outpatient arm) | 2 months |
| Worsening heart failure | Worsening of heart failure after the initiation of DPP-4 inhibitor. (only for the hospitalization arm) | 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) | Changes in plasma renin, aldosterone, serum stromal cell-derived factor 1 alpha, serum active glucagon-like peptide-1, serum active glucose-dependent insulinotropic polypeptide during the study period. | 3 days to 2 months |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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