Heart FailureMicroCRTNCT02396875
Selective Coronary Vein Sampling in Left Bundle Branch Block and CRT
A study testing Blood sampling and exercise protocol pre and post CRT implant, Peripheral blood sampling and Central blood sampling pre and post CRT implant 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) prolongs the life and improves the symptoms in patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve with the treatment which is both expensive and not without complication. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Blood sampling and exercise protocol pre and post CRT implant, Peripheral blood sampling and Central blood sampling pre and post CRT implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1/A:
- -Scheduled for CRT implant
- Group 2/B -Heart failure without electrical dyssynchrony.
- Group B:
- -Scheduled for angiography for clinical grounds
- Group 3/C -Patients without known heart disease
- Group C:
- -Scheduled for clinical angiography and found to have normal coronary arteries
Who cannot join
- Pregnancy
- Moderate to severe aortic valve disease
Trial locations and contacts
1 site in 1 country.
Christopher Rinaldi, MD MBBS contact
simon claridge, LLB MBBS contact
United Kingdom1 site
Guy's and St Thomas Hospital Trust
London, Se1 7EH
Simon Claridge, MBBS LLB, simon.claridge@kcl.ac.uk
Reza Razavi, MBBS MD, reza.razavi@kcl.ac.uk
About this study
Official title: Selective Coronary Vein Sampling in Dyssynchronous Heart Failure and Cardiac Resynchronisation Therapy to Assess Physiological Response to Exercise and Characterise Regional Release of Novel Biomarkers
Cardiac resynchronisation therapy (CRT) prolongs the life and improves the symptoms in patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve with the treatment which is both expensive and not without complication. Despite much research, we cannot accurately predict who will not respond. Furthermore, most heart failure patients gets symptoms on exercise and most studies have examined patients at rest. We propose to investigate the effect of exercise on different parts of the left ventricle by sampling various biomarkers of metabolism, myocardial injury and gene expression. We will then repeat the protocol following device insertion to look for changes. This novel work will require a small cohort of patients with heart failure and no electrical dyssynchrony and normal patients to act as controls. We will also measure novel biomarkers at different venous sites relating to different parts of the myocardium to determine whether they can be used to prognosticate or even predict response to CRT.
Read the detailed description
We propose to examine the acute effects of exercise on patients with dyssynchronous electrical activation of the heart and heart failure and to compare the release of novel biomarkers in selective areas of coronary venous drainage by direct cannulation of different veins via the coronary sinus (CS).
The study design will separate patients into a minimally invasive arm (MINARM)and an invasive arm (INARM). The INARM will be recruited from patients in the MINARM.
MINARM
Group 1: 40 patients scheduled for CRT implant Group 2: 15 patients with heart failure and no dyssynchrony Group 3: 15 patients with normal hearts
Group 1:
40 patient undergoing CRT will have venous samples taken from the CS, two CS tributaries, peripheral venous and peripheral arterial sites at the time of CRT insertion at the time of device implant. Blood samples will be analysed for metabolites and novel biomarkers
They will then undergo repeat sampling at 6 months to assess for changes in the micro RNA and biomarker profile including CS sampling.
Group 2 and 3
A control arm of 15 patients with heart failure and no dyssynchrony (Group 2) and 15 patients with normal hearts (Group 3) will undergo peripheral venous sampling for biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in micro RNA expression.
10 patient from Group 1 and 5 from Group 2 and 3 will be invited to from part of the INARM at the time of recruitment.
INARM study
Methods:
GROUP A 10 pts with heart failure and dyssynchronous ventricular contraction GROUP B 5 pts with heart failure and no electrical dyssynchrony schedule for either coronary angiography or electrophysiology study.
GROUP C 5 pts schedule for diagnostic coronary angiography or electrophysiology study with normal cardiac function
The exact details of the protocol will vary depending upon the Group:
GROUP A
1 On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. A pacing protocol will be performed using a pacing wire inserted into the right atrium. Coronary sinus venous blood sampling will be performed using a catheter placed via the femoral or internal jugular vein. At the chief investigator's discretion a specially designed exercise bicycle that allow supine exercise in the catheter lab will be used rather than the atrial pacing wire.
3 6 months post implant the patients will return to the catheter laboratory for a further study. This will repeat the protocol but with the device having been on for 6 months. This will require further arterial access as described above. This study should take approximately an hour.
GROUP B and C
It is common practice for these patients to have a coronary angiogram to exclude ischaemic heart disease as the cause of their heart failure or chest pain or to have electrophysiology study to determine the mechanism of arrhythmia. If their angiogram is normal,we will perform a pacing protocol (this will be required if they are attending for an electrophysiology study). This will require 2 femoral venous access sites (similar to standard electrophysiological study) to allow temporary atrial pacing and acquisition of blood samples from the coronary sinus. Following the invasive part of the study patients in Group B and C will fall back into Group 2 and 3 of MINARM and attend at 6 month for peripheral blood sampling.
- Conditions
- Heart Failure
- Being tested
- Blood sampling and exercise protocol pre and post CRT implant, Peripheral blood sampling, Central blood sampling pre and post CRT implant, Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and exercise protocol pre and post CRT implantProcedure or surgery
Peripheral blood samplingProcedure or surgery
Central blood sampling pre and post CRT implantProcedure or surgery
Central blood sampling on one occasion and exercise protocol and 6 month peripheral samplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 40 patients undergoing CRT will have venous samples taken from two CS tributaries, peripheral venous and peripheral arterial sites at the time of CRT insertion at the time of device implant. Blood samples will be analysed for metabolites and novel biomarkers They will then undergo repeat sampling at 6 months to assess for changes in the biomarker profile including CS sampling. Receives: Procedure: Central blood sampling pre and post CRT implant |
| Group 2 | Active comparator | A control arm of 15 patients with heart failure and no dyssynchrony will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression. Receives: Procedure: Peripheral blood sampling |
| Group 3 | Active comparator | A control arm of 15 patients with normal hearts will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression. Receives: Procedure: Peripheral blood sampling |
| Group A | Experimental | 10 patients from Group 1
On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. The patient will have a radial sheath positioned in the arterial system. A pacing protocol will be performed using a pacing wire inserted into the right atrium. Coronary sinus venous blood sampling will be performed using a catheter placed via the femoral or internal jugular vein. At the chief investigator's discretion a specially designed exercise bicycle that allow supine exercise in the catheter lab will be used rather than the atrial pacing wire.
6 months post implant the patients will return to the catheter laboratory for a further study. This will repeat the protocol but with the device having been on for 6 months. This will require further study as described above. Receives: Procedure: Blood sampling and exercise protocol pre and post CRT implant |
| Group B | Active comparator | 5 patients form Group 2.
Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 2 for 6 month follow up Receives: Procedure: Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling |
| Group C | Active comparator | 5 patients form Group 3
Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 3 for 6 month follow up Receives: Procedure: Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Various biomarkers measured from different coronary veins at rest and following exertion both pre CRT implant and at 6 months
Biomarkers and metabolites to be assessed include but are not limited to O2, lactate, glucose, CKMB, hs trop, galectin3, Soluble St2, Nt proBNP, cardiac myosin binding protein C, 10 different micro RNA associated with myocardial stress/damage
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
- Study completionDec 2016 (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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396875
- Sponsor's protocol ID
- 14/LO/1765
- Acronym
- MicroCRT
- Status last verified
- Mar 2015
- First submitted
- 24 Oct 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Coronary Vein Sampling in Dyssynchronous Heart Failure and Cardiac Resynchronisation Therapy to Assess Physiological Response to Exercise and Characterise Regional Release of Novel Biomarkers
- ClinicalTrials.gov ID
- NCT02396875
- Acronym / sponsor ID
- MicroCRT / 14/LO/1765
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Mar 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.
Cardiac resynchronisation therapy (CRT) prolongs the life and improves the symptoms in patients with heart failure and electrical dyssynchrony. 30-50% of patients do not improve with the treatment which is both expensive and not without complication. Despite much research, we cannot accurately predict who will not respond. Furthermore, most heart failure patients gets symptoms on exercise and most studies have examined patients at rest. We propose to investigate the effect of exercise on different parts of the left ventricle by sampling various biomarkers of metabolism, myocardial injury and gene expression. We will then repeat the protocol following device insertion to look for changes. This novel work will require a small cohort of patients with heart failure and no electrical dyssynchrony and normal patients to act as controls. We will also measure novel biomarkers at different venous sites relating to different parts of the myocardium to determine whether they can be used to prognosticate or even predict response to CRT.
Detailed description
We propose to examine the acute effects of exercise on patients with dyssynchronous electrical activation of the heart and heart failure and to compare the release of novel biomarkers in selective areas of coronary venous drainage by direct cannulation of different veins via the coronary sinus (CS).
The study design will separate patients into a minimally invasive arm (MINARM)and an invasive arm (INARM). The INARM will be recruited from patients in the MINARM.
MINARM
Group 1: 40 patients scheduled for CRT implant Group 2: 15 patients with heart failure and no dyssynchrony Group 3: 15 patients with normal hearts
Group 1:
40 patient undergoing CRT will have venous samples taken from the CS, two CS tributaries, peripheral venous and peripheral arterial sites at the time of CRT insertion at the time of device implant. Blood samples will be analysed for metabolites and novel biomarkers
They will then undergo repeat sampling at 6 months to assess for changes in the micro RNA and biomarker profile including CS sampling.
Group 2 and 3
A control arm of 15 patients with heart failure and no dyssynchrony (Group 2) and 15 patients with normal hearts (Group 3) will undergo peripheral venous sampling for biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in micro RNA expression.
10 patient from Group 1 and 5 from Group 2 and 3 will be invited to from part of the INARM at the time of recruitment.
INARM study
Methods:
GROUP A 10 pts with heart failure and dyssynchronous ventricular contraction GROUP B 5 pts with heart failure and no electrical dyssynchrony schedule for either coronary angiography or electrophysiology study.
GROUP C 5 pts schedule for diagnostic coronary angiography or electrophysiology study with normal cardiac function
The exact details of the protocol will vary depending upon the Group:
GROUP A
1 On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. A pacing protocol will be performed using a pacing wire inserted into the right atrium. Coronary sinus venous blood sampling will be performed using a catheter placed via the femoral or internal jugular vein. At the chief investigator's discretion a specially designed exercise bicycle that allow supine exercise in the catheter lab will be used rather than the atrial pacing wire.
3 6 months post implant the patients will return to the catheter laboratory for a further study. This will repeat the protocol but with the device having been on for 6 months. This will require further arterial access as described above. This study should take approximately an hour.
GROUP B and C
It is common practice for these patients to have a coronary angiogram to exclude ischaemic heart disease as the cause of their heart failure or chest pain or to have electrophysiology study to determine the mechanism of arrhythmia. If their angiogram is normal,we will perform a pacing protocol (this will be required if they are attending for an electrophysiology study). This will require 2 femoral venous access sites (similar to standard electrophysiological study) to allow temporary atrial pacing and acquisition of blood samples from the coronary sinus. Following the invasive part of the study patients in Group B and C will fall back into Group 2 and 3 of MINARM and attend at 6 month for peripheral blood sampling.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Central blood sampling pre and post CRT implant40 patients undergoing CRT will have venous samples taken from two CS tributaries, peripheral venous and peripheral arterial sites at the time of CRT insertion at the time of device implant. Blood samples will be analysed for metabolites and novel biomarkers They will then undergo repeat sampling at 6 months to assess for changes in the biomarker profile including CS sampling. |
| Group 2 | Active comparator | Procedure: Peripheral blood samplingA control arm of 15 patients with heart failure and no dyssynchrony will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression. |
| Group 3 | Active comparator | Procedure: Peripheral blood samplingA control arm of 15 patients with normal hearts will undergo peripheral venous sampling for novel biomarkers and this will be repeated at 6 months. These samples will allow for control against the dyssynchronous heart failure group and also for temporal changes in biomarker expression. |
| Group A | Experimental | Procedure: Blood sampling and exercise protocol pre and post CRT implant10 patients from Group 1 On the day preceding the CRT implant will attend hospital for a temporary invasive catheter study. The patient will have a radial sheath positioned in the arterial system. A pacing protocol will be performed using a pacing wire inserted into the right atrium. Coronary sinus venous blood sampling will be performed using a catheter placed via the femoral or internal jugular vein. At the chief investigator's discretion a specially designed exercise bicycle that allow supine exercise in the catheter lab will be used rather than the atrial pacing wire. 6 months post implant the patients will return to the catheter laboratory for a further study. This will repeat the protocol but with the device having been on for 6 months. This will require further study as described above. |
| Group B | Active comparator | Procedure: Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling5 patients form Group 2. Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 2 for 6 month follow up |
| Group C | Active comparator | Procedure: Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling5 patients form Group 3 Patients will undergo a pacing or exercise protocol and have venous, coronary sinus and arterial blood sampled. They will revert to Group 3 for 6 month follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -Scheduled for CRT implant
- Group 2/B -Heart failure without electrical dyssynchrony.
- -Scheduled for angiography for clinical grounds
- Group 3/C -Patients without known heart disease
- -Scheduled for clinical angiography and found to have normal coronary arteries
Key exclusion criteria (2 listed)
- Pregnancy
- Moderate to severe aortic valve disease
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 |
|---|---|---|
| Blood sampling and exercise protocol pre and post CRT implant | Procedure or surgery | Group A |
| Peripheral blood sampling | Procedure or surgery | Group 2, Group 3 |
| Central blood sampling pre and post CRT implant | Procedure or surgery | Group 1 |
| Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling | Procedure or surgery | Group B, Group C |
Primary outcome
Levels of Various biomarkers measured from different coronary veins at rest and following exertion both pre CRT implant and at 6 months
Time frame: 2 years
Biomarkers and metabolites to be assessed include but are not limited to O2, lactate, glucose, CKMB, hs trop, galectin3, Soluble St2, Nt proBNP, cardiac myosin binding protein C, 10 different micro RNA associated with myocardial stress/damage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
Christopher Rinaldi, MD MBBS contact
simon claridge, LLB MBBS 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 Blood sampling and exercise protocol pre and post CRT implant, Peripheral blood sampling and Central blood sampling pre and post CRT implant 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 8 inclusion and 2 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 24 Mar 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 Christopher Rinaldi, MD MBBS (aldo.rinaldi@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Various biomarkers measured from different coronary veins at rest and following exertion both pre CRT implant and at 6 months (time frame: 2 years). 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 24 Mar 2015.