Marfan SyndromePhase 4NCT01295047
Comparison of Medical Therapies in Marfan Syndrome.
A Phase 4 study testing Atenolol, VERAPAMIL and Perindopril in people with Marfan Syndrome, run by Cardiff University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Atenolol, VERAPAMIL and Perindopril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2006to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for Marfan syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wales Heart Research Institute, Cardiff University
Cardiff, CF14 4XN
About this study
Official title: Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial
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.
Read the 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.
- Conditions
- Marfan Syndrome
- Being tested
- Atenolol, VERAPAMIL, Perindopril
- Keywords
- Marfan Syndrome, Large arterial function, LV function, atenolol, perindopril, verapamil, central arterial pressure
- Medical subject headings
- Marfan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtenololDrug
VERAPAMILDrug
240 MG SR
PerindoprilDrug
4 MG
| Study group | Role | What they receive |
|---|---|---|
| ATENOLOL | Active comparator | ATENOLOL 75MG FOR 4 WEEKS Receives: Drug: Atenolol |
| VERAPAMIL | Active comparator | 240MG VERAPAML FOR 4 WEEKS Receives: Drug: VERAPAMIL |
| PERINDOPRIL | Active comparator | 4MG PERINDOPRIL FOR 4 WEEKS Receives: Drug: Perindopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
CENTRAL ARTERIAL PRESSURE
CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
Measured: 18 weeks
Secondary outcomes (2)
LARGE ARTERIAL STIFFNESS INDICES
MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY
Measured: 18 WEEKS
LV Function
GLOBAL AND REGIONAL MARKERS BY ECHO
Measured: 18 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marfan SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295047
- Sponsor's protocol ID
- SPONCU101
- Other IDs
- 2005-000749-13, 2005
- Status last verified
- Jan 2006
- First submitted
- 11 Feb 2011
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial
- ClinicalTrials.gov ID
- NCT01295047
- Acronym / sponsor ID
- SPONCU101
- Conditions
- Marfan Syndrome
- Keywords
- Marfan Syndrome, Large arterial function, LV function, atenolol, perindopril, verapamil, central arterial pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ATENOLOL | Active comparator | Drug: AtenololATENOLOL 75MG FOR 4 WEEKS |
| VERAPAMIL | Active comparator | Drug: VERAPAMIL240MG VERAPAML FOR 4 WEEKS |
| PERINDOPRIL | Active comparator | Drug: Perindopril4MG PERINDOPRIL FOR 4 WEEKS |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for Marfan syndrome
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atenolol | Drug | ATENOLOL |
| VERAPAMIL240 MG SR | Drug | VERAPAMIL |
| Perindopril4 MG | Drug | PERINDOPRIL |
Primary outcome
CENTRAL ARTERIAL PRESSURE
Time frame: 18 weeks
CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
2 secondary outcomes
LARGE ARTERIAL STIFFNESS INDICES
Time frame: 18 WEEKS
LV Function
Time frame: 18 WEEKS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atenolol, VERAPAMIL and Perindopril in people with Marfan Syndrome, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CENTRAL ARTERIAL PRESSURE (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2011.