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

NCT ID: NCT02312427

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Suspending DPP-4 inhibitor, in outpatient service

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Starting DPP-4 inhibitor after treatment of heart failure

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Suspending DPP-4 inhibitor after treatment of heart failure

Intervention Type 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.

Interventions

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Suspending DPP-4 inhibitor, in outpatient service

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.

Intervention Type DRUG

Starting DPP-4 inhibitor after treatment of heart failure

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.

Intervention Type DRUG

Suspending DPP-4 inhibitor after treatment of heart failure

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.

Intervention Type DRUG

Eligibility Criteria

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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.


* Type 2 diabetes patient who were hospitalized for congestive heart failure.
* 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


* Patients on insulin therapy.
* Judged as ineligible by clinical investigators.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsukoshi Health and Welfare Foundation

INDUSTRY

Sponsor Role collaborator

Mitsui Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akihiro Isogawa, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mitusui Memorial Hospital, Division of diabetes

Locations

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Mitsui Memorial Hospital

Taito-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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MMHMEC2014-10

Identifier Type: -

Identifier Source: org_study_id

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