search
Back to results

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

Primary Purpose

Marfan Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Losartan
Atenolol
Sponsored by
Forteza, Albert, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Marfan Syndrome focused on measuring Aortic dilation, Marfan syndrome, Losartan, Atenolol

Eligibility Criteria

5 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Vall d'Hebron
  • Hospital 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Losartan

Atenolol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2010
Last Updated
August 11, 2010
Sponsor
Forteza, Albert, M.D.
Collaborators
Ministry of Health, Spain
search

1. Study Identification

Unique Protocol Identification Number
NCT01145612
Brief Title
Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome
Acronym
LO-AT-MARFAN01
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Forteza, Albert, M.D.
Collaborators
Ministry of Health, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marfan Syndrome
Keywords
Aortic dilation, Marfan syndrome, Losartan, Atenolol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Experimental
Arm Description
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
Arm Title
Atenolol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression of aortic dilation in patients with Marfan syndrome.
Description
Evaluate the eficacy of Losartan versus Atenolol in the progression of aortic dilation in patients with Marfan syndrome.
Time Frame
Until February 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Women who are pregnant, suspected to be pregnant or breast-feeding. Ongoing participation in another clinical trial or who received the investigational drug in the month prior to the inclusion in the study. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Forteza, Dr
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arturo Evangelista, Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28045
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs