Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome (LO-AT-MARFAN01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Forteza, Albert, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by:
Forteza, Albert, M.D.
ClinicalTrials.gov Identifier:
NCT01145612
First received: June 15, 2010
Last updated: August 11, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilatation in patients with Marfan syndrome.


Condition Intervention Phase
Marfan Syndrome
Drug: Losartan
Drug: Atenolol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Clinical Trial to Assess the Efficacy and Safety of Losartan Versus Atenolol in the Prevention of Progressive Dilation of the Aorta in Patients With Marfan Syndrome.

Resource links provided by NLM:


Further study details as provided by Forteza, Albert, M.D.:

Primary Outcome Measures:
  • Progression of aortic dilation in patients with Marfan syndrome. [ Time Frame: Until February 2013 ] [ Designated as safety issue: No ]
    Evaluate the eficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.


Enrollment: 140
Study Start Date: October 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Losartan
Losartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
Drug: Losartan
Losartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
Experimental: Atenolol
Atenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
Drug: Atenolol
Atenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg

Detailed Description:

Marfan syndrome is a genetic disease of the connective tissue. Patients with Marfan syndrome experience an expansion of the aorta that can lead to dissection or rupture of it. This is the main cause of mortality in these patients.

The main objective of this study is to evaluate the efficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.

The measurement is made by echocardiography, assessing the diameter of the aorta in different zones: valve annulus, sinuses of Valsalva, sinotubular junction, ascending aorta, aortic arch, thoracic and abdominal aorta.

A total number of 150 subjects diagnosed with Marfan syndrome and who meet the diagnostic criteria of Ghent, of both sexes, 75 per treatment group, aged between 5 and 60, will be included in the study. The study is being conducted in two Spanish hospitals.

The treatment is maintained throughout the study period.

  Eligibility

Ages Eligible for Study:   5 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145612

Locations
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08023
Hospital 12 de Octubre
Madrid, Spain, 28045
Sponsors and Collaborators
Forteza, Albert, M.D.
Ministry of Health, Spain
Investigators
Principal Investigator: Alberto Forteza, Dr
Principal Investigator: Arturo Evangelista, Dr
  More Information

No publications provided

Responsible Party: Dr Alberto Forteza
ClinicalTrials.gov Identifier: NCT01145612     History of Changes
Other Study ID Numbers: LO-AT-MARFAN-01, 2007-001125-97
Study First Received: June 15, 2010
Last Updated: August 11, 2010
Health Authority: Spain: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee

Keywords provided by Forteza, Albert, M.D.:
Aortic dilation
Marfan syndrome
Losartan
Atenolol

Additional relevant MeSH terms:
Marfan Syndrome
Arachnodactyly
Dilatation, Pathologic
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Pathological Conditions, Anatomical
Atenolol
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists

ClinicalTrials.gov processed this record on July 31, 2014