Clinical trial NCT02312427: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Diabetes Mellitus
Lead sponsor: Mitsui Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Mitsukoshi Health and Welfare Foundation
First posted: 2014-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Serum BNP level with and without DPP-4 inhibitor use.
timeFrame: 3 days to 2 months
Secondary outcomes:
measure: All cause mortality
timeFrame: 2 months
measure: Cardiovascular death
timeFrame: 2 months
measure: Heart failure hospitalization
timeFrame: 2 months
measure: Worsening heart failure
timeFrame: 3 days
measure: Echocardiographic measures (Changes in echocardiographic measures during the study period.)
timeFrame: 3 days to 2 months
measure: 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)
timeFrame: 3 days to 2 months
Other outcomes:
Locations:
city: Taito-ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
Study officials:
affiliation: Mitusui Memorial Hospital, Division of diabetes
name: Akihiro Isogawa, M.D.
role: PRINCIPAL_INVESTIGATOR
References: