Clinical trial: Oral Nifedipine to Treat Iron Overload (NCT00712738)

Eligibility criteria:
-  INCLUSION CRITERIA:

        Iron overloaded subjects will have a history of iron overload that may be due to a variety
        of causes including genetic hemochromatosis or thalassemia or other transfusion-dependent
        anemias (e.g. sickle cell syndromes, aplastic anemia, ineffective erythropoiesis) or other
        causes. Entry into the study requires that all subjects possess at least minimal evidence
        of iron overload at the time of entry (defined as serum ferritin and serum transferrin
        saturations levels above the normal range). Among fifty (50) subjects recruited for this
        protocol, at least twenty (20) with significant iron overload (defined in this study as
        ferritin greater than 500 ng/ml and transferrin saturation greater than (50%) will be
        included.

        All subjects will be of adult age (greater than or equal to 18 yrs).

        All subjects enrolled in this protocol will have a primary physician and care in the
        community that is capable of managing any medical problems unrelated to the nifedipine
        regimen.

        All subjects must be able to provide informed consent.

        EXCLUSION CRITERIA:

        Allergy to nifedipine.

        Patient receiving calcium channel blocker therapy within 7 days prior to enrollment.

        Blood transfusion within 7 days of first urine iron evaluation.

        Pregnant or lactating women.

        Patients with GFR less than 60 ml/min.

        Albumin less than 3g/dl.

        Significant hemoglobinuria (greater than1+ on urinalysis).

        Hemoglobin less than 10 g/dl

        Uncompensated cardiac disease including decreased ejection fraction detected by
        echocardiogram, angina, hypotension (less than 90mmHg systolic pressure) or symptomatic
        arrhythmias. Documented myocardial infarction within one year prior to the study.

        Use of tea, Vitamin C, iron chelation therapy, iron supplements, grapefruit juice,
        cimetidine, digitalis, quinidine, or beta-blockers (due to potential for increased serum
        drug levels versus cardiovascular risk) within 7 days prior to the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? 1