NCT01295047

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

February 14, 2011

Status Verified

January 1, 2006

Enrollment Period

1.4 years

First QC Date

February 11, 2011

Last Update Submit

February 11, 2011

Conditions

Marfan Syndrome

Keywords

Marfan SyndromeLarge arterial functionLV functionatenololperindoprilverapamilcentral arterial pressure

Outcome Measures

Primary Outcomes (1)

  • CENTRAL ARTERIAL PRESSURE

    CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY

    18 weeks

Secondary Outcomes (2)

  • LARGE ARTERIAL STIFFNESS INDICES

    18 WEEKS

  • LV Function

    18 WEEKS

Study Arms (3)

ATENOLOL

ACTIVE COMPARATOR

ATENOLOL 75MG FOR 4 WEEKS

Drug: Atenolol

VERAPAMIL

ACTIVE COMPARATOR

240MG VERAPAML FOR 4 WEEKS

Drug: VERAPAMIL

PERINDOPRIL

ACTIVE COMPARATOR

4MG PERINDOPRIL FOR 4 WEEKS

Drug: Perindopril

Interventions

AtenololDRUG
ATENOLOL
VERAPAMILDRUG

240 MG SR

VERAPAMIL
PerindoprilDRUG

4 MG

PERINDOPRIL

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wales Heart Research Institute, Cardiff University

Cardiff, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Marfan Syndrome

Interventions

AtenololVerapamilPerindopril

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

July 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

February 14, 2011

Record last verified: 2006-01

Locations

GB(1)