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

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312427
• Other study ID #: MMHMEC2014-10
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2014
• Last updated: March 20, 2018
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2018
• Source: Mitsui Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Heart Failure

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Mitsui Memorial Hospital	Taito-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Mitsui Memorial Hospital	Mitsukoshi Health and Welfare Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All cause mortality	Any deaths during the study period. (only for the outpatient arm)	2 months
Secondary	Cardiovascular death	Any cardiovascular deaths during the study period. (only for the outpatient arm)	2 months
Secondary	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)	2 months
Secondary	Worsening heart failure	Worsening of heart failure after the initiation of DPP-4 inhibitor. (only for the hospitalization arm)	3 days
Secondary	Echocardiographic measures (Changes in echocardiographic measures during the study period.)		3 days to 2 months
Secondary	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.	3 days to 2 months