Clinical trial: Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome (NCT01145612)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects must conform to the diagnostic criteria Marfan syndrome according to the
             Ghent Criteria.

          2. Outpatient subjects.

          3. Male or female, aged between 5 and 60 years.

          4. Women who are in a childbearing age are required a result of negative Gonadotropin
             pregnancy test to be included in the study.

          5. Subjects must be able to take oral medication.

          6. After having received information about the study, subjects must understand the nature
             of it and give written informed consent.

          7. For Subjects under 18 years, the informed consent must be signed by their parents or
             guardians.

          8. Subjects with a maximum diameter of the aorta, at length, <45 mm

          9. Female subjects of childbearing potential must be willing to avoid pregnancy by using
             an adequate method of contraception for four weeks prior to, during and three months
             after the last dose study medication.

        For the purposes of this study, women of childbearing potential is defined as: All female
        subjects after puberty unless they are post-menopausal for at least two years, or are
        surgically sterile. Adequate contraception is defined as two barrier methods, or one
        barrier method with a spermicide, or an intrauterine device or use of the oral female
        contraceptive (or other hormonal methods).

        Exclusion Criteria:

          1. Women who are pregnant, suspected to be pregnant or breast-feeding.

          2. Ongoing participation in another clinical trial or who received the investigational
             drug in the month prior to the inclusion in the study.

          3. Known or suspected failure to comply with the study protocol.

          4. Previous surgery: cardiac or at any segment of the aorta.

          5. Functional class III-IV.

          6. Maximum diameter of the aorta exceeding 45 mm

          7. More than moderate valvular involvement.

          8. History or presence of respiratory failure, liver (ALT> 3 x ULN), renal (creatinine
             clearance <30 mL / min), gastrointestinal, hematological, endocrine, or any other
             situation that may affect the assessment of the study treatment, according to the
             investigator opinion.

          9. History of aortic dissection.

         10. History or presence of neurological disease (especially seizures, dementia ...).

         11. History or presence of alcohol abuse and / or toxic substances

         12. Uncontrolled depression.

         13. Any need for another antihypertensive treatment (betablockers, diuretics, calcium
             channel blockers, ACE inhibitors, ARBs, etc.)

         14. Hypersensitivity, intolerance or contraindication to any component of the study drug.

         15. Patients with a history of drug abuse or toxic dependence.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications.  Vital signs are normal.  On physical examination, the patient is tall with long upper extremities and fingers.  The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw.  The lungs are clear on auscultation.  The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver.

Patient description (patient's own words): I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since.

Does the patient match the trial criteria? 1