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

Sponsor

Mitsui Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02312427

Collaborator

Mitsukoshi Health and Welfare Foundation (Industry)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Diabetes Mellitus	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	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	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.
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Experimental: 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.

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

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

Serum BNP level with and without DPP-4 inhibitor use. [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.

Secondary Outcome Measures

All cause mortality [2 months]
Any deaths during the study period. (only for the outpatient arm)
Cardiovascular death [2 months]
Any cardiovascular deaths during the study period. (only for the outpatient arm)
Heart failure hospitalization [2 months]
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)
Worsening heart failure [3 days]
Worsening of heart failure after the initiation of DPP-4 inhibitor. (only for the hospitalization arm)
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mitsui Memorial Hospital	Taito-ku	Tokyo	Japan

Sponsors and Collaborators

Mitsui Memorial Hospital
Mitsukoshi Health and Welfare Foundation

Investigators

Principal Investigator: Akihiro Isogawa, M.D., Mitusui Memorial Hospital, Division of diabetes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitsui Memorial Hospital

ClinicalTrials.gov Identifier:

NCT02312427

Other Study ID Numbers:

MMHMEC2014-10

First Posted:

Dec 9, 2014

Last Update Posted:

Mar 22, 2018

Last Verified:

Mar 1, 2018

Additional relevant MeSH terms:

Heart Failure

Dipeptidyl-Peptidase IV Inhibitors

Study Results

No Results Posted as of Mar 22, 2018