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

JRCT ID: jRCTs051180123

Registered date:13/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dilated cardiomyopathy
• Date of first enrollment: 15/01/2013
• Target sample size: 2
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Change in plasma BNP levels

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Onoue Kenji