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Comparison of Medical Therapies in Marfan Syndrome.

This study has been completed.
Sponsor:
Information provided by:
Cardiff University
ClinicalTrials.gov Identifier:
NCT01295047
First received: February 11, 2011
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Marfan Syndrome
Drug: Atenolol
Drug: VERAPAMIL
Drug: Perindopril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial

Resource links provided by NLM:


Further study details as provided by Cardiff University:

Primary Outcome Measures:
  • CENTRAL ARTERIAL PRESSURE [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY


Secondary Outcome Measures:
  • LARGE ARTERIAL STIFFNESS INDICES [ Time Frame: 18 WEEKS ] [ Designated as safety issue: No ]
    MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY

  • LV Function [ Time Frame: 18 WEEKS ] [ Designated as safety issue: No ]
    GLOBAL AND REGIONAL MARKERS BY ECHO


Enrollment: 18
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ATENOLOL
ATENOLOL 75MG FOR 4 WEEKS
Drug: Atenolol
Active Comparator: VERAPAMIL
240MG VERAPAML FOR 4 WEEKS
Drug: VERAPAMIL
240 MG SR
Active Comparator: PERINDOPRIL
4MG PERINDOPRIL FOR 4 WEEKS
Drug: Perindopril
4 MG

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

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295047

Locations
United Kingdom
Wales Heart Research Institute, Cardiff University
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
Cardiff University
  More Information

No publications provided

Responsible Party: DR ALAN FRASER, WALES HEART RESEARCH INSTITUTE
ClinicalTrials.gov Identifier: NCT01295047     History of Changes
Other Study ID Numbers: SPONCU101, 2005-000749-13
Study First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cardiff University:
Marfan Syndrome
Large arterial function
LV function
atenolol
perindopril
verapamil
central arterial pressure

Additional relevant MeSH terms:
Arachnodactyly
Marfan Syndrome
Syndrome
Abnormalities, Multiple
Bone Diseases
Bone Diseases, Developmental
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Connective Tissue Diseases
Disease
Genetic Diseases, Inborn
Heart Defects, Congenital
Heart Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Pathologic Processes
Atenolol
Perindopril
Verapamil
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Calcium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014