DPP-4 Inhibitor and Serum BNP Level of Diabetic Patients With Congestive Heart Failure

Mitsui Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus; Heart Failure

Treatments: Drug: Suspending DPP-4 inhibitor, in outpatient service; Drug: Suspending DPP-4 inhibitor after treatment of heart failure; Drug: Starting DPP-4 inhibitor after treatment of heart failure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02312427

MMHMEC2014-10

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Outpatient arm

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Outpatient arm

Experimental group

Description:

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.

Treatment:

Drug: Suspending DPP-4 inhibitor, in outpatient service

Hospitalization arm 1

Experimental group

Description:

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.

Treatment:

Drug: Starting DPP-4 inhibitor after treatment of heart failure

Hospitalization arm 2

Experimental group

Description:

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.

Treatment:

Drug: Suspending DPP-4 inhibitor after treatment of heart failure