Heart Failure, CongestivePhase 2/3INCREMENTALNCT00399594
Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.
A Phase 2/3 study testing A and B in people with Heart Failure, Congestive and Cardiac Pacing, Artificial, run by University of Calgary at 3 sites in Canada.
Trial summary
Identifying \& optimizing strategies to reduce the burden of heart failure is vital. Despite advances in pharmacotherapy, patients with heart failure are at high risk for death \& hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Cardiac Pacing, Artificial, Defibrillators
- What is being tested?
- A and B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2011to Nov 2015
- 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
- LV EF ≤ 0.40 measured within 3 months of enrollment,
- SAS class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment.
- Confirmed dyssynchrony on screening echo (1.1.9), \&
- On stable doses of ACE inhibitor or angiotensin II blocker \& a beta-blocker for ≥ 2 months unless medically contra-indicated.
- Controlled heart rate if in permanent AF (resting <70 \& maximal <120).
Who cannot join
- Unable or unwilling to provide informed consent,
- Medical condition other than heart failure likely to cause death < 1 year,
- Cardiac transplant planned within 6 months,
- Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously),
- Clinically significant myocardial infarction within last 2 months, or
- Coronary bypass graft surgery ≤ 2 months or coronary angioplasty ≤ 1 month
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Foothills Hospital
Calgary, Alberta, T2N4N1
London Health Sciences
London, Ontario
Quebec Heart Institute
Ste-Foy, Quebec, G1V4G5
About this study
Official title: Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL).
Identifying \& optimizing strategies to reduce the burden of heart failure is vital. Despite advances in pharmacotherapy, patients with heart failure are at high risk for death \& hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output \& reduces HF symptoms. However, ~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.
This study will assess whether targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.
Read the detailed description
Background. Identifying \& optimizing strategies to reduce the burden of heart failure (HF) is vital. Despite advances in pharmacotherapy, patients with HF are at high risk for death \& hospitalization. Over 25% of patients with systolic HF have dyssynchronous ventricular contraction that results in paradoxical septal motion, further impairing left ventricular (LV) function \& HF progression. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output \& reduces HF symptoms. However, ~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.
Screening. Mechanical synchrony is vitally important in optimizing CRT response. Patients will be pre-screened with echocardiograms (echo) \& CRT provided to only those with dyssynchrony. The predicted rate of CRT response in patients pre-screened for dyssynchrony is estimated at 65%.
CRT response. The combined use of a valid \& simple measure of functional capacity with a reproducible measure of LV volume is optimal in identifying CRT responders. These outcomes will be assessed using the Specific Activity Scale \& radionuclide angiography (RNA), respectively.
Primary hypothesis. Targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement. CRT response will be defined as ≥ 10% relative reduction in LV end systolic volume \& ≥ 1 Specific Activity Scale class improvement.
- Being tested
- A, B
- Keywords
- Mechanical dyssynchrony, Biventricular pacing, 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.
AProcedure or surgery
LV lead placement in region of latest mechanical velocity (tissue doppler)
BProcedure or surgery
LV lead placement in standard (lateral / posterolateral) position.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Targeted LV lead placement Receives: Procedure: A |
| B | Active comparator | Usual LV lead placement Receives: Procedure: B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in end systolic volume plus reduction in symptoms
Measured: over 12 months
Secondary outcomes (9)
Minnesota Living with Heart Failure score.
Measured: Change over 12 months
Short form thirty six score.
Measured: Change over 12 months
Specific Activity Scale score.
Measured: Change over 12 months
New York Heart Association class.
Measured: Change over 12 months
Six minute walk distance.
Measured: Change over 12 months
LV volumes.
Measured: Change over 12 months
N-terminal pro-B-type natriuretic peptide.
Measured: Change over 12 months
Mortality
Measured: Study duration
Hospitalization
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Medtronic, Hoffmann-La Roche, Cambridge Heart Inc.
- Responsible party
- Principal investigator, Dr. Derek Exner, University of Calgary
- Investigators
- Derek V Exner, MD, MPH, Principal investigator, Libin Cardiovascular Institute of Alberta, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399594
- Sponsor's protocol ID
- CAH 70-3402
- Acronym
- INCREMENTAL
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2006
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL).
- ClinicalTrials.gov ID
- NCT00399594
- Acronym / sponsor ID
- INCREMENTAL / CAH 70-3402
- Keywords
- Mechanical dyssynchrony, Biventricular pacing, Cardiac resynchronization therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Medtronic, Hoffmann-La Roche, Cambridge Heart Inc.
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Nov 2006 (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.
Identifying \& optimizing strategies to reduce the burden of heart failure is vital. Despite advances in pharmacotherapy, patients with heart failure are at high risk for death \& hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output \& reduces HF symptoms. However, ~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.
This study will assess whether targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.
Detailed description
Background. Identifying \& optimizing strategies to reduce the burden of heart failure (HF) is vital. Despite advances in pharmacotherapy, patients with HF are at high risk for death \& hospitalization. Over 25% of patients with systolic HF have dyssynchronous ventricular contraction that results in paradoxical septal motion, further impairing left ventricular (LV) function \& HF progression. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output \& reduces HF symptoms. However, ~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response.
Screening. Mechanical synchrony is vitally important in optimizing CRT response. Patients will be pre-screened with echocardiograms (echo) \& CRT provided to only those with dyssynchrony. The predicted rate of CRT response in patients pre-screened for dyssynchrony is estimated at 65%.
CRT response. The combined use of a valid \& simple measure of functional capacity with a reproducible measure of LV volume is optimal in identifying CRT responders. These outcomes will be assessed using the Specific Activity Scale \& radionuclide angiography (RNA), respectively.
Primary hypothesis. Targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement. CRT response will be defined as ≥ 10% relative reduction in LV end systolic volume \& ≥ 1 Specific Activity Scale class improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: ATargeted LV lead placement |
| B | Active comparator | Procedure: BUsual LV lead placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LV EF ≤ 0.40 measured within 3 months of enrollment,
- SAS class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment.
- Confirmed dyssynchrony on screening echo (1.1.9), \&
- On stable doses of ACE inhibitor or angiotensin II blocker \& a beta-blocker for ≥ 2 months unless medically contra-indicated.
- Controlled heart rate if in permanent AF (resting <70 \& maximal <120).
Key exclusion criteria (6 listed)
- Unable or unwilling to provide informed consent,
- Medical condition other than heart failure likely to cause death < 1 year,
- Cardiac transplant planned within 6 months,
- Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously),
- Clinically significant myocardial infarction within last 2 months, or
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 |
|---|---|---|
| ALV lead placement in region of latest mechanical velocity (tissue doppler) | Procedure or surgery | A |
| BLV lead placement in standard (lateral / posterolateral) position. | Procedure or surgery | B |
Primary outcome
Change in end systolic volume plus reduction in symptoms
Time frame: over 12 months
9 secondary outcomes
Minnesota Living with Heart Failure score.
Time frame: Change over 12 months
Short form thirty six score.
Time frame: Change over 12 months
Specific Activity Scale score.
Time frame: Change over 12 months
New York Heart Association class.
Time frame: Change over 12 months
Six minute walk distance.
Time frame: Change over 12 months
LV volumes.
Time frame: Change over 12 months
N-terminal pro-B-type natriuretic peptide.
Time frame: Change over 12 months
Mortality
Time frame: Study duration
Hospitalization
Time frame: Study duration
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 24 Nov 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.
Derek V Exner, MD, MPH principal investigator
Libin Cardiovascular Institute of Alberta, University of Calgary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing A and B in people with Heart Failure, Congestive and Cardiac Pacing, Artificial, run by University of Calgary at 3 sites in Canada.
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 5 inclusion and 6 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 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
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?
Change in end systolic volume plus reduction in symptoms (time frame: over 12 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 24 Nov 2015.