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NCT Number: NCT02312427

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mitsui Memorial Hospital

Taito-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suspending DPP-4 inhibitor, in outpatient service

Drug

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

Drug

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

Drug

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 outcomes

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

    Time frame: 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 outcomes

  1. All cause mortality

    Time frame: 2 months

    Any deaths during the study period. (only for the outpatient arm)

  2. Cardiovascular death

    Time frame: 2 months

    Any cardiovascular deaths during the study period. (only for the outpatient arm)

  3. Heart failure hospitalization

    Time frame: 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)

  4. Worsening heart failure

    Time frame: 3 days

    Worsening of heart failure after the initiation of DPP-4 inhibitor. (only for the hospitalization arm)

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

    Time frame: 3 days to 2 months

  6. 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mitsui Memorial Hospital

Other

Collaborators

  • Mitsukoshi Health and Welfare Foundation

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2014
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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