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Clinical Trial Details

Trial ID: L1941
Source ID: NCT02312427
Associated Drug: Suspending Dpp-4 Inhibitor, In Outpatient Service
Title: DPP-4 Inhibitor and Serum BNP Level of Diabetic Patients With Congestive Heart Failure
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Heart Failure|Diabetes Mellitus
Interventions: DRUG: Suspending DPP-4 inhibitor, in outpatient service|DRUG: Starting DPP-4 inhibitor after treatment of heart failure|DRUG: Suspending DPP-4 inhibitor after treatment of heart failure
Outcome Measures: Primary: 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 | Secondary: 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), 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
Sponsor/Collaborators: Sponsor: Mitsui Memorial Hospital | Collaborators: Mitsukoshi Health and Welfare Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-01
Completion Date: 2016-03
Results First Posted:
Last Update Posted: 2018-03-22
Locations: Mitsui Memorial Hospital, Taito-ku, Tokyo, Japan
URL: https://clinicaltrials.gov/show/NCT02312427