Heart FailureNCT03258060
CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
A study testing Temporary pacing study and Body Surface Mapping in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). 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?
- Temporary pacing study and Body Surface Mapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to 18 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- NYHA grade III-IV heart failure
- LVEF<35%
- QRS duration <120ms
- On optimum medical therapy for heart failure
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- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- • Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- Participant who is terminally ill or is inappropriate for placebo medication
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Contraindication to an MRI scan
- Rate uncontrolled atrial fibrillation precluding a cMR
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- Significant peripheral vascular disease precluding an EP study
- A contraindication to anticoagulation
- A prosthetic aortic or tricuspid valve
- Significant Aortic valve disease
- Known LV thrombus
- Insufficient capacity to consent to the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cardiovascular Imaging, King's College London
London, SE1 7EF
About this study
Official title: Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see if cardiac MRI can be used to select patients with normal electrical conduction for CRT, therefore expanding the number of people who would stand to benefit from this treatment.
- Conditions
- Heart Failure
- Being tested
- Temporary pacing study, Body Surface Mapping
- Keywords
- Heart Failure, Pacing, Resynchronization, Electrophysiology, Imaging, Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary pacing studyProcedure or surgery
Also called Electrophysiological study
Body Surface MappingRadiation
Also called ECG imaging
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Dyssynchrony | Active comparator | Those with cardiac MRI evidence of mechanical dyssynchrony Receives: Procedure: Temporary pacing study; Radiation: Body Surface Mapping |
| No Mechanical Dyssynchrony | Active comparator | Those without mechanical dyssynchrony on cardiac MRI Receives: Procedure: Temporary pacing study; Radiation: Body Surface Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV dP/dT during pacing
To assess LV dP/dT during different pacing modalities by intraventricular pressure wire. A dP/dT change of >10% from baseline is a positive result.
Measured: during temporary pacing study, approximately 2 hours
Secondary outcomes (1)
Correlation of electrical and mechanical dyssynchrony
To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping
Measured: Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study startApr 2014
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Why it stopped: release of other trial indicating futility of this study after recruitment of 1 patient
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 Guy's and St Thomas' NHS Foundation TrustThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Aldo Rinaldi, MBBS MD FHRS, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258060
- Sponsor's protocol ID
- nQRS-CRT
- Status last verified
- Aug 2017
- First submitted
- 17 Mar 2014
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
- ClinicalTrials.gov ID
- NCT03258060
- Acronym / sponsor ID
- nQRS-CRT
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Pacing, Resynchronization, Electrophysiology, Imaging, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: release of other trial indicating futility of this study after recruitment of 1 patient
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Apr 2014
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 23 Aug 2017 (actual)
- 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.
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see if cardiac MRI can be used to select patients with normal electrical conduction for CRT, therefore expanding the number of people who would stand to benefit from this treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Dyssynchrony | Active comparator | Procedure: Temporary pacing study, Radiation: Body Surface MappingThose with cardiac MRI evidence of mechanical dyssynchrony |
| No Mechanical Dyssynchrony | Active comparator | Procedure: Temporary pacing study, Radiation: Body Surface MappingThose without mechanical dyssynchrony on cardiac MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (12 listed)
- • Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
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 |
|---|---|---|
| Temporary pacing studyAlso: Electrophysiological study | Procedure or surgery | Mechanical Dyssynchrony, No Mechanical Dyssynchrony |
| Body Surface MappingAlso: ECG imaging | Radiation | Mechanical Dyssynchrony, No Mechanical Dyssynchrony |
Primary outcome
LV dP/dT during pacing
Time frame: during temporary pacing study, approximately 2 hours
To assess LV dP/dT during different pacing modalities by intraventricular pressure wire. A dP/dT change of >10% from baseline is a positive result.
1 secondary outcome
Correlation of electrical and mechanical dyssynchrony
Time frame: Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months
Results and safety
The study was stopped early (reason given: release of other trial indicating futility of this study after recruitment of 1 patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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.
Aldo Rinaldi, MBBS MD FHRS principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary pacing study and Body Surface Mapping in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 23 Aug 2017. 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?
The study was stopped early (reason given: release of other trial indicating futility of this study after recruitment of 1 patient). Results are not available in the source record.
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?
LV dP/dT during pacing (time frame: during temporary pacing study, approximately 2 hours). 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 23 Aug 2017.