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Heart FailurePhase 4NCT02312427

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

A Phase 4 study testing Suspending DPP-4 inhibitor, in outpatient service, Starting DPP-4 inhibitor after treatment of heart failure and Suspending DPP-4 inhibitor after treatment of heart failure in people with Heart Failure and Diabetes Mellitus, run by Mitsui Memorial Hospital at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Heart Failure, Diabetes Mellitus
What is being tested?
Suspending DPP-4 inhibitor, in outpatient service, Starting DPP-4 inhibitor after treatment of heart failure and Suspending DPP-4 inhibitor after treatment of heart failure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteJapan
Study dates
Jan 2015to Mar 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Type 2 diabetes patient who were hospitalized for congestive heart failure.
  • Patients who have given informed consent to participation in the study.

Who cannot join

  • HbA1c over 9.0%.
  • Patients who changed medication within 1 months before inclusion.
  • Judged as ineligible by clinical investigators.
  • Hospitalization arm
  • Patients on insulin therapy.
  • Judged as ineligible by clinical investigators.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Mitsui Memorial Hospital

    Taito-ku, Tokyo

Other trials in Japan

About this study

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.

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.

Being tested
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
Medical subject headings
Heart Failure, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

Study groups in NCT02312427
Study groupRoleWhat they receive
Outpatient armExperimentalAfter 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.
Receives: Drug: Suspending DPP-4 inhibitor, in outpatient service
Hospitalization arm 1ExperimentalAfter 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.
Receives: Drug: Starting DPP-4 inhibitor after treatment of heart failure
Hospitalization arm 2ExperimentalAfter 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.
Receives: Drug: Suspending DPP-4 inhibitor after treatment of heart failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 days to 2 months

Secondary outcomes (6)

  1. All cause mortality

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

    Measured: 2 months

  2. Cardiovascular death

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

    Measured: 2 months

  3. 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)

    Measured: 2 months

  4. Worsening heart failure

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

    Measured: 3 days

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

    Measured: 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)

    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.

    Measured: 3 days to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02312427
Sponsor's protocol ID
MMHMEC2014-10
Status last verified
Mar 2018
First submitted
30 Nov 2014
Last updated
22 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Suspending DPP-4 inhibitor, in outpatient service, Starting DPP-4 inhibitor after treatment of heart failure and Suspending DPP-4 inhibitor after treatment of heart failure in people with Heart Failure and Diabetes Mellitus, run by Mitsui Memorial Hospital at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum BNP level with and without DPP-4 inhibitor use. (time frame: 3 days to 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02312427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.

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