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Clinical study on the efficacy of flutamide for androgen dependent dilated cardiomyopathy

Clinical study on the efficacy of flutamide for androgen dependent dilated cardiomyopathy - FLUADE DCM trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051180123
Enrollment
2
Registered
2019-03-13
Start date
2013-01-15
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

Dilated cardiomyopathy Dilated cardiomyopathy

Interventions

arm flutamide: Firstly flutamide 62.5 mg given orally on once daily and gradually dose of flutamide increased to 375 mg three times daily, until applicable the discontinuance criteria.

Sponsors

Onoue Kenji
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with androgen dependent familial dilated cardiomyopathy. 2. Patients who are sufficiently understood that standard treatments indicate no adequate therapeutic efficacy. 3. Patients who are sufficiently understood that the efficacy and safety of flutamide was not yet fully secured. 4. Patients who are able to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity to flutamide. 2. Patients with hepatic impairment. 3. Patients who are not able to provide signed informed consent.

Design outcomes

Primary

MeasureTime frame
Change in plasma BNP levels

Secondary

MeasureTime frame
Change in New York Heart Association (NYHA) classification. Change in left ventricular (LV) diastolic diameter, LV systolic diameter, LV ejection fraction, right ventricular fractional area change and left atrial diameter. Change in cardiothoracic ratio. Change in Hemoglobin levels, creatinine levels and sodium level and potassium levels.

Contacts

Public ContactTomoya Nakano

Nara Medical University Hospital

tnakano@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

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