NCT02312427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 heart-failure

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

November 30, 2014

Last Update Submit

March 20, 2018

Conditions

Heart FailureDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • All cause mortality

    2 months

  • Cardiovascular death

    2 months

  • Heart failure hospitalization

    2 months

  • Worsening heart failure

    3 days

  • Echocardiographic measures (Changes in echocardiographic measures during the study period.)

    3 days to 2 months

  • +1 more secondary outcomes

Study Arms (3)

Outpatient arm

EXPERIMENTAL

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

Hospitalization arm 1

EXPERIMENTAL

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

Hospitalization arm 2

EXPERIMENTAL

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

Interventions

Suspending DPP-4 inhibitor, in outpatient serviceDRUG

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.

Outpatient arm
Starting DPP-4 inhibitor after treatment of heart failureDRUG

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 1
Suspending DPP-4 inhibitor after treatment of heart failureDRUG

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.

Hospitalization arm 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • HbA1c over 9.0%.
  • Judged as ineligible by clinical investigators.
  • Hospitalization arm
  • Type 2 diabetes patient who were hospitalized for congestive heart failure.
  • Patients who have given informed consent to participation in the study.
  • Patients on insulin therapy.
  • Judged as ineligible by clinical investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mitsui Memorial Hospital

Taito-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Heart FailureDiabetes Mellitus

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Akihiro Isogawa, M.D.

    Mitusui Memorial Hospital, Division of diabetes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2014

First Posted

December 9, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

JP(1)