Heart FailureNCT02434159
Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy
A study testing Heart scan in people with Heart Failure, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Sep 2017
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18, <90
- Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
- QRS duration >120ms on 12 lead ECG
- LVEF < 35%
- LVEDD >55 mm
- Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.
Who cannot join
- Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
- Patients who had had an atrial arrhythmia within one month prior to recruitment
- Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
- Patients with a heart rate of more than 140 beats per minute
- Patients with severe renal failure (eGFR < 30)
- Patients with a history of allergy to iodine based contrast agents
- Predicted life expectancy < 1 year
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Vanessa Cobb contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
Vanessa Cobb, nesscobb@hotmail.com
About this study
Official title: Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy
The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.
- Conditions
- Heart Failure
- Being tested
- Heart scan
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart scanOther
| Study group | Role | What they receive |
|---|---|---|
| Scan | Active comparator | Heart scan prior to device insertion Receives: Other: Heart scan |
| No scan | No intervention | No heart scan prior to device insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2012
- Primary completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434159
- Sponsor's protocol ID
- 11/0583
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2015
- Last updated
- 5 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy
- ClinicalTrials.gov ID
- NCT02434159
- Acronym / sponsor ID
- 11/0583
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2017 (estimated)
- First posted
- 5 May 2015 (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 purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scan | Active comparator | Other: Heart scanHeart scan prior to device insertion |
| No scan | No intervention | –No heart scan prior to device insertion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18, <90
- Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
- QRS duration >120ms on 12 lead ECG
- LVEF < 35%
- LVEDD >55 mm
Key exclusion criteria (8 listed)
- Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
- Patients who had had an atrial arrhythmia within one month prior to recruitment
- Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
- Patients with a heart rate of more than 140 beats per minute
- Patients with severe renal failure (eGFR < 30)
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 |
|---|---|---|
| Heart scan | Other | Scan |
Primary outcome
6 minute walk test
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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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.
Vanessa Cobb contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart scan in people with Heart Failure, run by University College, London 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 May 2015. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Cobb (nesscobb@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: 6 months). 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 5 May 2015.