Back to results

Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers

Primary Purpose

Marfan Syndrome

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Losartan

Placebo

About this trial

This is an interventional treatment trial for Marfan Syndrome

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients > 10 years
Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage
Consent obtained (written) either for the patient and for his/her parents (<18y
Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted)
ARB naïve patients

Exclusion Criteria:

Poor echocardiographic window,limiting the accurate measurement of the aortic root
Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia
Intolerance for ARB (eg angioedema)
Pregnancy or breast feeding women
Absence of effective contraception
Liver function abnormalities
Heart Failure
Patients included in other clinical trial

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Losartan

Placebo

Outcomes

Primary Outcome Measures

The decrease of rate of aortic root growth measured by echocardiography at level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score.

Secondary Outcome Measures

Comparative arterial stiffness

Evaluation of progression of aortic regurgitation

Aortic dissection incidence

Aortic root surgery

Progression of mitral regurgitation

Left ventricular size and function

Skeletal and somatic traits

Quality of life

Genetic polymorphisms affecting clinical symptoms and response to treatment

Death

Aortic stiffness as assessed by MRI

Full Information

NCT ID

NCT00782327

First Posted

October 29, 2008

Last Updated

December 21, 2022

Sponsor

University Hospital, Ghent

Collaborators

Agentschap voor Innovatie door Wetenschap en Technologie

1. Study Identification

Unique Protocol Identification Number

NCT00782327

Brief Title

Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers

Official Title

Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2009 (Actual)

Primary Completion Date

November 26, 2014 (Actual)

Study Completion Date

November 26, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

Collaborators

Agentschap voor Innovatie door Wetenschap en Technologie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be compared to placebo. Losartan or placebo will be added to the treatment regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be guided by the tolerance of the drug by the patients. Patients will be contacted by phone call for assessment of side-effects before second step of uptitration. Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marfan Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Losartan

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Losartan

Intervention Description

Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Daily placebo capsule

Primary Outcome Measure Information:

Title

The decrease of rate of aortic root growth measured by echocardiography at level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score.

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Secondary Outcome Measure Information:

Title

Comparative arterial stiffness

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Evaluation of progression of aortic regurgitation

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Aortic dissection incidence

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Aortic root surgery

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Progression of mitral regurgitation

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Left ventricular size and function

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Skeletal and somatic traits

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Quality of life

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Genetic polymorphisms affecting clinical symptoms and response to treatment

Time Frame

End of study

Title

Death

Time Frame

At baseline and after 6 months, 1, 2 and 3 years follow-up

Title

Aortic stiffness as assessed by MRI

Time Frame

At baseline and after 1 year and 3 years follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients > 10 years Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage Consent obtained (written) either for the patient and for his/her parents (<18y Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted) ARB naïve patients Exclusion Criteria: Poor echocardiographic window,limiting the accurate measurement of the aortic root Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia Intolerance for ARB (eg angioedema) Pregnancy or breast feeding women Absence of effective contraception Liver function abnormalities Heart Failure Patients included in other clinical trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie De Backer, MD, PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website of the University Hospital Ghent

Learn more about this trial

Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers

We'll reach out to this number within 24 hrs