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

Primary Purpose

Heart Failure, Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Suspending DPP-4 inhibitor, in outpatient service
Starting DPP-4 inhibitor after treatment of heart failure
Suspending DPP-4 inhibitor after treatment of heart failure
Sponsored by
Mitsui Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mitsui Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Outpatient arm

Hospitalization arm 1

Hospitalization arm 2

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All cause mortality
Any deaths during the study period. (only for the outpatient arm)
Cardiovascular death
Any cardiovascular deaths during the study period. (only for the outpatient arm)
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)
Worsening heart failure
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.)
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.

Full Information

First Posted
November 30, 2014
Last Updated
March 20, 2018
Sponsor
Mitsui Memorial Hospital
Collaborators
Mitsukoshi Health and Welfare Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02312427
Brief Title
DPP-4 Inhibitor and Serum BNP Level of Diabetic Patients With Congestive Heart Failure
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsui Memorial Hospital
Collaborators
Mitsukoshi Health and Welfare Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient arm
Arm Type
Experimental
Arm 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.
Arm Title
Hospitalization arm 1
Arm Type
Experimental
Arm 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.
Arm Title
Hospitalization arm 2
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Suspending DPP-4 inhibitor, in outpatient service
Intervention Description
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
Intervention Name(s)
Starting DPP-4 inhibitor after treatment of heart failure
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Suspending DPP-4 inhibitor after treatment of heart failure
Intervention 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.
Primary Outcome Measure Information:
Title
Serum BNP level with and without DPP-4 inhibitor use.
Description
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.
Time Frame
3 days to 2 months
Secondary Outcome Measure Information:
Title
All cause mortality
Description
Any deaths during the study period. (only for the outpatient arm)
Time Frame
2 months
Title
Cardiovascular death
Description
Any cardiovascular deaths during the study period. (only for the outpatient arm)
Time Frame
2 months
Title
Heart failure hospitalization
Description
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)
Time Frame
2 months
Title
Worsening heart failure
Description
Worsening of heart failure after the initiation of DPP-4 inhibitor. (only for the hospitalization arm)
Time Frame
3 days
Title
Echocardiographic measures (Changes in echocardiographic measures during the study period.)
Time Frame
3 days to 2 months
Title
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)
Description
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.
Time Frame
3 days to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akihiro Isogawa, M.D.
Organizational Affiliation
Mitusui Memorial Hospital, Division of diabetes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mitsui Memorial Hospital
City
Taito-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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