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Comparison of Medical Therapies in Marfan Syndrome.

Information source: Cardiff University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Marfan Syndrome

Intervention: Atenolol (Drug); VERAPAMIL (Drug); Perindopril (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cardiff University

Summary

The investigators are looking at the different impacts of atenolol, verapamil and perindopril on large artery and lv function in marfan syndrome. It is a double-blind, randomised cross-over trial.

Clinical Details

Official title: Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: CENTRAL ARTERIAL PRESSURE

Secondary outcome:

LARGE ARTERIAL STIFFNESS INDICES

LV Function

Detailed description: The investigators recruited 21 patients with confirmed diagnosis of Marfan syndrome from two centres. The investigators performed radial artery applanation tonometry and pulse wave analysis to derive central aortic pressure and haemodynamic indexes pre-and post administering Atenolol 75mg, Perindopril 4mg and Verapamil 240mgs each for four weeks with a two week wash-out between medications. All patients underwent detailed functional and anatomical echocardiographic assessments at each visit. Inclusion criteria were ages 16-60 years with no treatment or β-blocker or other monotherapy only for Marfan syndrome. Patients with previous aortic dissection or aortic surgery, severe valvular regurgitation, aortic diameter at the sinotubular junction ≥ 5. 0cm, contraindications to specific drug treatment, e. g. asthma and β-blocker, or those who were pregnant or at risk of pregnancy were excluded.

Eligibility

Minimum age: 16 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for

Marfan syndrome Exclusion Criteria:

- Previous aortic dissection or aortic surgery

- Severe valvular regurgitation

- Aortic diameter at the sinotubular junction ≥ 5. 0cm

- Contraindications to specific drug treatment, e. g. asthma and β-blocker

- Those who were pregnant or at risk of pregnancy

Locations and Contacts

Wales Heart Research Institute, Cardiff University, Cardiff CF14 4XN, United Kingdom
Additional Information

Starting date: July 2006
Last updated: February 11, 2011

Page last updated: August 23, 2015

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