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Evaluation of Losartan on Cardiovascular Disease in Patients With Mucopolysaccharidoses IV A and VI

NCT03632213 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-12-19

No results posted yet for this study

Summary

Mucopolysaccharidoses (MPS) are multisystemic diseases with significant clinical overlap between their types, with cardiac problems being among the most commonly observed manifestations and are also among the main causes of mortality in these patients. For some of the cardiovascular manifestations, such as aortic root dilation and valve diseases, there is no effective treatment currently available. Losartan, on the other hand, has been shown to be an effective drug for dilation of the aortic root, at least in animal models. This study aims to evaluate the safety and efficacy of losartan in patients with MPS VI and other mucopolysaccharidoses.

Conditions

  • Mucopolysaccharidosis IV A
  • Mucopolysaccharidosis VI
  • Mucopolysaccharidoses
  • MPS IV A
  • MPS VI
  • MPS - Mucopolysaccharidosis
  • Morquio A Syndrome
  • Morquio Syndrome A
  • Morquio Syndrome

Interventions

DRUG

Losartan

Losartan group: 15 patients, both sexes, will receive Losartan 0.4 to 1.4 mg/kg/day orally for 12 months.

DRUG

Placebo

Placebo group: 15 patients, both sexes, will receive oral placebo for 12 months.

Sponsors & Collaborators

  • The Isaac Foundation

    collaborator UNKNOWN

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Roberto Giugliani, MD, PhD · Hospital de Clinicas de Porto Alegre

  • Guilherme Baldo, PhD · Hospital de Clinicas de Porto Algre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2023-05-04
Completion
2023-08-03

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632213 on ClinicalTrials.gov