Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome

NCT01145612 | Unknown Phase 3

• 2 other identifiers: LO-AT-MARFAN-012007-001125-97
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Marfan Syndrome

Keywords

Aortic dilation; Marfan syndrome; Losartan; Atenolol

Outcome Measures

Primary Outcomes (1)

• Progression of aortic dilation in patients with Marfan syndrome.

  Evaluate the eficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.

  Until February 2013

Study Arms (2)

Losartan

EXPERIMENTAL

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

Atenolol

EXPERIMENTAL

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

Interventions

Losartan DRUG

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

Losartan

Atenolol DRUG

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

Atenolol

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects must conform to the diagnostic criteria Marfan syndrome according to the Ghent Criteria.
• Outpatient subjects.
• Male or female, aged between 5 and 60 years.
• Women who are in a childbearing age are required a result of negative Gonadotropin pregnancy test to be included in the study.
• Subjects must be able to take oral medication.
• After having received information about the study, subjects must understand the nature of it and give written informed consent.
• For Subjects under 18 years, the informed consent must be signed by their parents or guardians.
• Subjects with a maximum diameter of the aorta, at length, \<45 mm
• 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).

You may not qualify if:

• Women who are pregnant, suspected to be pregnant or breast-feeding.
• Known or suspected failure to comply with the study protocol.
• Previous surgery: cardiac or at any segment of the aorta.
• Functional class III-IV.
• Maximum diameter of the aorta exceeding 45 mm
• More than moderate valvular involvement.
• 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.
• History of aortic dissection.
• History or presence of neurological disease (especially seizures, dementia ...).
• History or presence of alcohol abuse and / or toxic substances
• Uncontrolled depression.
• Any need for another antihypertensive treatment (betablockers, diuretics, calcium channel blockers, ACE inhibitors, ARBs, etc.)
• Hypersensitivity, intolerance or contraindication to any component of the study drug.
• Patients with a history of drug abuse or toxic dependence.

Sponsors & Collaborators

• Forteza, Albert, M.D.: lead
• Ministry of Health, Spain: collaborator

Study Sites (2)

Hospital Vall d'Hebron

Barcelona, Barcelona, 08023, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28045, Spain

Location

MeSH Terms

Conditions

Marfan Syndrome

Interventions

Losartan; Atenolol

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• Alberto Forteza, Dr

  PRINCIPAL INVESTIGATOR

• Arturo Evangelista, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 16, 2010
• Study Start: October 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 12, 2010

Record last verified: 2010-06

Locations

ES (2)