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A multicenter study of clinical usefulness of flow-mediated vasodilation B

A multicenter study of clinical usefulness of flow-mediated vasodilation B - FMD-J multicenter study B

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000012951
Enrollment
598
Registered
2014-01-24
Start date
2010-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hypertension or diabetes mellitus

Interventions

None listed

Sponsors

FMD Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Enrolled patients are those with hypertension or diabetes mellitus, whose conditions are being well-controled with treatment (ie, blood pressure of <150/95 mmHg and HbA1c level of <7.5%), and who have been receiving follow-up at 1 of the participating centers for at least 6 months.

Exclusion criteria

Exclusion criteria: The exclusion criteria are: the presence of coronary artery disease, including a history of percutaneous coronary intervention or coronary bypass surgery; severe valvular heart disease; arrhythmia requiring treatment (ie, atrial fibrillation, atrial flutter, permanent pacemaker implantation or frequent ventricular premature beats); impaired left ventricular systolic function (left ventricular ejection fraction of <40%); malignancy; receiving treatment with steroids, nonsteroidal anti-inflammatory drugs or immunosuppressive drugs; a serum creatinine level of greater than 2.5 mg/dL; stroke or aortic disease (except peripheral artery disease) and serious liver disease.

Design outcomes

Primary

MeasureTime frame
1) Ultrasound examination of the carotid artery: max intima-media thickness (IMT), mean IMT. 2) Urinary microalbumin and creatinine excretion measurements.

Secondary

MeasureTime frame
Ultrasound examination of the carotid artery: plaque score

Countries

Japan

Contacts

Public ContactYukihito Higashi

Research Institute for Radiation Biology and Medicine 1

yhigashi@hiroshima-u.ac.jp082-257-5831

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026