NCT04330079

Brief Summary

The purpose of this study is to investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (MPR) using dynamic SPECT examination in prediabetic patients with stable CAD. Dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable CAD.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2020

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

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

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

March 30, 2020

Last Update Submit

September 21, 2022

Conditions

Coronary Artery DiseasePrediabetic State

Keywords

DapagliflozinLifestyle modificationMyocardial perfusion reserve

Outcome Measures

Primary Outcomes (1)

  • Percent change in global myocardial perfusion reserve (MPR) index

    6months

Secondary Outcomes (5)

  • Percent change in regional myocardial perfusion reserve (MPR) index

    6months

  • absolute changes in global MPR index

    6months

  • absolute changes in regional MPR index

    6months

  • Change in body weight

    6months

  • Change in blood pressure(systolic, diastolic both )

    6months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL
Drug: Dapagliflozin 10mg

Lifestyle modification

OTHER
Other: Lifestyle modification

Interventions

Dapagliflozin 10mgDRUG

Dapagliflozin 10mg once daily for 6 months.

Dapagliflozin
Lifestyle modificationOTHER

lifestyle modification (diet and exercise) for 6 months

Lifestyle modification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women at least 18 years of age
  • Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
  • Stable coronary artery disease
  • Global myocardial perfusion reserve (MPR) index \< 2.0
  • The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

You may not qualify if:

  • Contraindications to dapagliflozin
  • Significant renal disease manifested by eGFR\<30 ml/min/1.73m²
  • Unstable or rapidly progressing renal disease
  • Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
  • Stent placement, or coronary artery bypass graft surgery within the previous 6 months
  • Planned revascularization within 6 months
  • Significant disease (diameter stenosis \>70% by coronary CT angiography) in major epicardial coronary arteries
  • Heart failure requiring loop diuretics
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
  • Contraindication to adenosine stress test
  • Current treatment for the active cancer
  • Women of child bearing potential who are not willing to use a medically accepted method of contraception. Patient's pregnancy confirmed by positive pregnancy test, or breast-feeding.
  • Expected life expectancy \< 1 year
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests which, in the judgment of the investigator, would preclude safe completion of the study.
  • Unwillingness or inability to comply with the procedures described in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseasePrediabetic State

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cheol Whan Lee, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

May 21, 2020

Primary Completion

April 8, 2021

Study Completion

April 8, 2021

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations

KR(1)