Heart FailurePhase 2/3NCT01464502
Pressure Wire Guided Cardiac Resynchronisation Therapy
A Phase 2/3 study testing Standard CRT Implant and Pressure-wire guided CRT implant in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 10 sites in 2 countries.
Trial summary
Heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Standard CRT Implant and Pressure-wire guided CRT implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2012to Apr 2018
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling standard criteria for CRT
- Ischaemic or non-ischaemic heart failure
Who cannot join
- Contraindication to pressure wire assessment including:
- Severe aortic valve disease
- Mechanical aortic valve replacement
- Severe peripheral vascular disease
- LV thrombus
Trial locations and contacts
10 sites in 2 countries.
Christopher Aldo Rinaldi, MBBS, MD contact
10 sites in 2 countries
United Kingdom8 sites, 8 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham
Francisco Leyva, MD
- Recruiting
Royal Bournemouth Hospital
Bournemouth
John Paisey
- Recruiting
Medway Maritime Hospital
Gillingham, Kent
Shaumik Adhya, MBBS
- Recruiting
Guy's and St. Thomas' NHS Foundation NHS Trust
London, London, SE1 7EH
Manav Sohal, BSc, MBBS, 00447939061486, manav.sohal@gstt.nhs.uk
Manav Sohal, BSc, MBBS
- Recruiting
Queen Elizabeth Hospital Woolwich
London
Shoaib Hamid, MD
- Recruiting
The Heart Hospital
London
Pier Lambiase, MD
- Recruiting
Freeman Hospital
Newcastle upon Tyne
Janet McCoomb, MD
- Recruiting
John Radcliffe Hospital
Oxford
Tim Betts, MD
Italy2 sites, 2 recruiting
- Recruiting
Hospital Auxolgico
Milan
Giovanni Prerego, MD
- Recruiting
San Rafaelle Hospital
Milan
Nicoleta Sora, MD
About this study
Official title: A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study
Heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. Only two thirds of people respond to CRT and this may be because of non-ideal pacing wire position. A potential marker for response is the change in heart pump pressure change over time. The aim of this study is to use a specialised wire in the main pumping chamber of the heart to record the pressure changes with the pacing lead in various positions to determine the optimal position. It is postulated that the improved pressure changes will increase the proportion of responders.
Pilot study work has shown that the work is technically feasible and safe. The initial data has been published in a highly regarded scientific journal. This main study will be a multicentre randomised controlled trial whereby patients will be randomised to either standard treatment or pressure wireguided treatment. The patients in the pressurewire guided arm will have a specialised wire implanted into the main pumping chamber of their heart via a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will measure acute pressure changes over time and the pacing lead will be positioned in the site that gives the greatest change in pressure.
If the patients in the pressurewire guided arm fare better than those receiving standard treatment it may alter how a large proportion of heart failure patients are treated around the world. The study requires 282 patients and is likely to take two years to complete.
- Conditions
- Heart Failure
- Being tested
- Standard CRT Implant, Pressure-wire guided CRT implant
- Keywords
- Heart failure, Cardiac resynchronisation therapy, Acute haemodynamic response, Responder
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CRT ImplantProcedure or surgery
Pressure-wire guided CRT implantProcedure or surgery
A pressure wire will be sited in the left ventricle to measure dP/dT max. The LV lead position that gives the highest dP/dT max will be the final position used.
| Study group | Role | What they receive |
|---|---|---|
| Standard CRT Implant | Active comparator | Not described Receives: Procedure: Standard CRT Implant |
| Pressure-wire guided CRT Implant | Active comparator | Not described Receives: Procedure: Pressure-wire guided CRT implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of CRT responders at 6 months
Measured: 6 months
Change in clinical composite score at 6 months
Measured: 6 months
Secondary outcomes (14)
Change in echo derived endsystolic volume (ESV) at six months
Measured: 6 months
Change in echo derived enddiastolic colume (EDV) at six months
Measured: 6 months
Change in echo derived left ventricular ejection fraction (LVEF) at 6 months
Measured: 6 months
Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)
Measured: 6 months
Six month change in 6 minute walk distance
Measured: 6 months
Six month change in VO2 max (CPET)
Measured: 6 months
Six month change in ntProBNP
Measured: 6 months
Six month difference in hospital readmission (days)
Measured: 6 months
Six month difference in mortality
Measured: 6 months
Difference in rates of successful LV lead implantation
Measured: One week
Difference in procedure duration
Measured: One week
Difference in radiation dose
Measured: One week
Difference in contrast dose
Measured: One week
Procedural complications
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 posted3 Nov 2011 (estimated)
- Study startSep 2012
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464502
- Sponsor's protocol ID
- 11/LO/1879
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2011
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study
- ClinicalTrials.gov ID
- NCT01464502
- Acronym / sponsor ID
- 11/LO/1879
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiac resynchronisation therapy, Acute haemodynamic response, Responder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Sep 2012
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 3 Nov 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.
Heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. Only two thirds of people respond to CRT and this may be because of non-ideal pacing wire position. A potential marker for response is the change in heart pump pressure change over time. The aim of this study is to use a specialised wire in the main pumping chamber of the heart to record the pressure changes with the pacing lead in various positions to determine the optimal position. It is postulated that the improved pressure changes will increase the proportion of responders.
Pilot study work has shown that the work is technically feasible and safe. The initial data has been published in a highly regarded scientific journal. This main study will be a multicentre randomised controlled trial whereby patients will be randomised to either standard treatment or pressure wireguided treatment. The patients in the pressurewire guided arm will have a specialised wire implanted into the main pumping chamber of their heart via a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will measure acute pressure changes over time and the pacing lead will be positioned in the site that gives the greatest change in pressure.
If the patients in the pressurewire guided arm fare better than those receiving standard treatment it may alter how a large proportion of heart failure patients are treated around the world. The study requires 282 patients and is likely to take two years to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard CRT Implant | Active comparator | Procedure: Standard CRT Implant |
| Pressure-wire guided CRT Implant | Active comparator | Procedure: Pressure-wire guided CRT implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients fulfilling standard criteria for CRT
- Ischaemic or non-ischaemic heart failure
Key exclusion criteria (5 listed)
- Contraindication to pressure wire assessment including:
- Severe aortic valve disease
- Mechanical aortic valve replacement
- Severe peripheral vascular disease
- LV thrombus
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 |
|---|---|---|
| Standard CRT Implant | Procedure or surgery | Standard CRT Implant |
| Pressure-wire guided CRT implantA pressure wire will be sited in the left ventricle to measure dP/dT max. The LV lead position that gives the highest dP/dT max will be the final position used. | Procedure or surgery | Pressure-wire guided CRT Implant |
Primary outcome
Change in the proportion of CRT responders at 6 months
Time frame: 6 months
Change in clinical composite score at 6 months
Time frame: 6 months
14 secondary outcomes
Change in echo derived endsystolic volume (ESV) at six months
Time frame: 6 months
Change in echo derived enddiastolic colume (EDV) at six months
Time frame: 6 months
Change in echo derived left ventricular ejection fraction (LVEF) at 6 months
Time frame: 6 months
Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)
Time frame: 6 months
Six month change in 6 minute walk distance
Time frame: 6 months
Six month change in VO2 max (CPET)
Time frame: 6 months
Six month change in ntProBNP
Time frame: 6 months
Six month difference in hospital readmission (days)
Time frame: 6 months
Six month difference in mortality
Time frame: 6 months
Difference in rates of successful LV lead implantation
Time frame: One week
Difference in procedure duration
Time frame: One week
Difference in radiation dose
Time frame: One week
Difference in contrast dose
Time frame: One week
Procedural complications
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 4 Apr 2017.
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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.
Christopher Aldo Rinaldi, MBBS, MD contact
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Standard CRT Implant and Pressure-wire guided CRT implant in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 10 sites in 2 countries.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Italy. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Manav Sohal, BSc, MBBS (00447939061486, manav.sohal@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the proportion of CRT responders at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 4 Apr 2017.