Heart FailureNCT00955539
Viability and Cardiac Resynchronization Therapy
A study testing AV-optimization followed by AV- and VV-optimization and AV- and VV-optimization followed by AV-optimization only. in people with Heart Failure and Ischemic Cardiomyopathy, run by University Hospital, Gentofte, Copenhagen at 2 sites in 2 countries.
Trial summary
30% of heart failure patients that receive a device for cardiac resynchronization therapy fail to show clinical improvement. The reason for lack of response is still unclear but factors such as scar tissue in the heart musculature, inadequate lead placement, device-settings and the degree of dyssynchrony before… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ischemic Cardiomyopathy
- What is being tested?
- AV-optimization followed by AV- and VV-optimization and AV- and VV-optimization followed by AV-optimization only.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2009to Jun 2013
- 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
- LVEF</= 35%, QRS-duration>/= 120 ms, NYHA-class II- IV.
- Ischemic heart disease (> 50% stenosis in 1 or more major epicardial coronary artery or prior PCI or CABG.)
- Optimal treatment ( beta-blocker, ACE-1 or ARB and spironolactone)
Who cannot join
- Pregnancy
- Unstable angina pectoris
- Chronical atrial fibrillation
- Severe valvular disease
- Dementia or mental retardation
- Severe claustrophobia
Show all 10Show fewer
- Acute myocardial infarction < 3 months
- Severe health condition threatening short-term survival
- Severe kidney insufficiency, GFR < 35 ml/min/1.73 m2
- Metal implants contraindicative of magnetic resonance scan
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Gentofte University Hospital
Hellerup, 2900
Niels Risum, M.D., +45 39978473, nieris01@geh.regionh.dk
Thomas Fritz Hansen, M.D., +45 39773977, THHAN@geh.regionh.dk
Sweden1 site, 1 recruiting
- Recruiting
University Hospital Lund
Lund, Lund, 221 85
Rasmus Borgquist, MD, PhD, +46 70-4057350, rasmus.borgquist@med.lu.se
Rasmus Borgquist, MD, PhD
About this study
Official title: The Importance of Viability for Response to Cardiac Resynchronization Therapy
30% of heart failure patients that receive a device for cardiac resynchronization therapy fail to show clinical improvement. The reason for lack of response is still unclear but factors such as scar tissue in the heart musculature, inadequate lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. In this study, these factors are further investigated.
Read the detailed description
Cardiac resynchronization therapy (CRT) is an established therapy for patients with severe heart failure, depressed left ventricular function and a wide QRS-complex. Large clinical trials have demonstrated unequivocal improvements in functional status, morbidity and mortality. However, 30 % of heart failure patients treated with a CRT-device do not benefit clinically. Several factors have been suggested to be important for the response to CRT such as mechanical dyssynchrony, presence of scar tissue in the myocardium, and device-optimization (among others). It is the purpose of this study to investigate the importance of these factors.
100 patients with ischemic cardiomyopathy, eligible to CRT according to current guidelines, will be included. Patients are randomised to two arms. One group will have atrioventricular (AV)-optimization after implantation, the other AV -and interventricular (VV)-optimization. After 4 months patients are crossed-over to the other arm. Preimplantation patients are MR-scanned and low-dose dobutamine stress-echocardiography is performed. Furthermore patients will be examined by echocardiography and evaluation of clinical status
- Mechanical dyssynchrony can predict response to CRT. b. Measures of mechanical dyssynchrony is related to myocardial viability and conduction.
- Individual optimization based on conduction times will increase benefit to CRT. b. The effect of adding VV-optimization is related to myocardial viability.
- > 30 % of non-viable tissue globally in the myocardium is predictive of lack of CRT- response. b. Non-viable tissue located in the area of the left ventricular lead is predictive of non-response.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Being tested
- AV-optimization followed by AV- and VV-optimization, AV- and VV-optimization followed by AV-optimization only.
- Keywords
- Heart Failure, Cardiac resynchronization therapy, Optimization, Viability, Mechanical dyssynchrony
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-optimization followed by AV- and VV-optimizationDevice
Patients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months.
AV- and VV-optimization followed by AV-optimization only.Device
Patients are AV- and VV-optimized the first 4 months,then AV-optimized the next 4 months.
| Study group | Role | What they receive |
|---|---|---|
| CRT group 1 | Active comparator | Not described Receives: Device: AV-optimization followed by AV- and VV-optimization |
| CRT group 2 | Active comparator | Not described Receives: Device: AV- and VV-optimization followed by AV-optimization only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders:Echocardiographic:>/= 10% increase in Left ventricular ejection fraction (LVEF) or >/= 15 % reduction in left ventricular end-systolic volume (LVESV)
Measured: 4 and 8 months, ( follow up- 2 years)
Secondary outcomes (2)
LVESV, LVEDV, Cardiac output (CO), Minnesota Living with Heart Failure Questionnaire (MLHFQ) ProBNP Others: t-wave modulation all-cause mortality, cardiac death, hospitalization
Measured: 4 and 8 months (follow-up after 2 years)
Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class
Measured: 4 and 8 months (follow-up 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Niels Risum, University Hospital, Gentofte, Copenhagen
- Investigators
- Niels Risum, M.D., Principal investigator, University Hospital Gentofte, Department of cardiologyThomas Fritz Hansen, M.D., Study chair, University Hospital Gentofte, department of cardiologyPeter Søgaard, M.D., DMSc., Study chair, Gentofte University Hospital, department of cardiologyRasmus Borgquist, MD, PhD, Study chair, University Hospital LundNiels E Bruun, MD, DMSc, Study chair, Gentofte University Hospital, department of cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955539
- Sponsor's protocol ID
- H-B-2009-057
- Status last verified
- Oct 2011
- First submitted
- 7 Aug 2009
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bax JJ, Abraham T, Barold SS, Breithardt OA, Fung JW, Garrigue S, Gorcsan J 3rd, Hayes DL, Kass DA, Knuuti J, Leclercq C, Linde C, Mark DB, Monaghan MJ, Nihoyannopoulos P, Schalij MJ, Stellbrink C, Yu CM. Cardiac resynchronization therapy: Part 1--issues before device implantation. J Am Coll Cardiol. 2005 Dec 20;46(12):2153-67. doi: 10.1016/j.jacc.2005.09.019.
PubMed 16360042Sogaard P, Egeblad H, Pedersen AK, Kim WY, Kristensen BO, Hansen PS, Mortensen PT. Sequential versus simultaneous biventricular resynchronization for severe heart failure: evaluation by tissue Doppler imaging. Circulation. 2002 Oct 15;106(16):2078-84. doi: 10.1161/01.cir.0000034512.90874.8e.
PubMed 12379577Bleeker GB, Kaandorp TA, Lamb HJ, Boersma E, Steendijk P, de Roos A, van der Wall EE, Schalij MJ, Bax JJ. Effect of posterolateral scar tissue on clinical and echocardiographic improvement after cardiac resynchronization therapy. Circulation. 2006 Feb 21;113(7):969-76. doi: 10.1161/CIRCULATIONAHA.105.543678. Epub 2006 Feb 13.
PubMed 16476852Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
PubMed 15753115
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Viability for Response to Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT00955539
- Acronym / sponsor ID
- H-B-2009-057
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Keywords
- Heart Failure, Cardiac resynchronization therapy, Optimization, Viability, Mechanical dyssynchrony
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Lund University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Aug 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 10 Aug 2009 (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.
30% of heart failure patients that receive a device for cardiac resynchronization therapy fail to show clinical improvement. The reason for lack of response is still unclear but factors such as scar tissue in the heart musculature, inadequate lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. In this study, these factors are further investigated.
Detailed description
Cardiac resynchronization therapy (CRT) is an established therapy for patients with severe heart failure, depressed left ventricular function and a wide QRS-complex. Large clinical trials have demonstrated unequivocal improvements in functional status, morbidity and mortality. However, 30 % of heart failure patients treated with a CRT-device do not benefit clinically. Several factors have been suggested to be important for the response to CRT such as mechanical dyssynchrony, presence of scar tissue in the myocardium, and device-optimization (among others). It is the purpose of this study to investigate the importance of these factors.
100 patients with ischemic cardiomyopathy, eligible to CRT according to current guidelines, will be included. Patients are randomised to two arms. One group will have atrioventricular (AV)-optimization after implantation, the other AV -and interventricular (VV)-optimization. After 4 months patients are crossed-over to the other arm. Preimplantation patients are MR-scanned and low-dose dobutamine stress-echocardiography is performed. Furthermore patients will be examined by echocardiography and evaluation of clinical status
- Mechanical dyssynchrony can predict response to CRT. b. Measures of mechanical dyssynchrony is related to myocardial viability and conduction.
- Individual optimization based on conduction times will increase benefit to CRT. b. The effect of adding VV-optimization is related to myocardial viability.
- > 30 % of non-viable tissue globally in the myocardium is predictive of lack of CRT- response. b. Non-viable tissue located in the area of the left ventricular lead is predictive of non-response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT group 1 | Active comparator | Device: AV-optimization followed by AV- and VV-optimization |
| CRT group 2 | Active comparator | Device: AV- and VV-optimization followed by AV-optimization only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LVEF</= 35%, QRS-duration>/= 120 ms, NYHA-class II- IV.
- Ischemic heart disease (> 50% stenosis in 1 or more major epicardial coronary artery or prior PCI or CABG.)
- Optimal treatment ( beta-blocker, ACE-1 or ARB and spironolactone)
Key exclusion criteria (10 listed)
- Pregnancy
- Unstable angina pectoris
- Chronical atrial fibrillation
- Severe valvular disease
- Dementia or mental retardation
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 |
|---|---|---|
| AV-optimization followed by AV- and VV-optimizationPatients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months. | Device | CRT group 1 |
| AV- and VV-optimization followed by AV-optimization only.Patients are AV- and VV-optimized the first 4 months,then AV-optimized the next 4 months. | Device | CRT group 2 |
Primary outcome
Responders:Echocardiographic:>/= 10% increase in Left ventricular ejection fraction (LVEF) or >/= 15 % reduction in left ventricular end-systolic volume (LVESV)
Time frame: 4 and 8 months, ( follow up- 2 years)
2 secondary outcomes
LVESV, LVEDV, Cardiac output (CO), Minnesota Living with Heart Failure Questionnaire (MLHFQ) ProBNP Others: t-wave modulation all-cause mortality, cardiac death, hospitalization
Time frame: 4 and 8 months (follow-up after 2 years)
Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class
Time frame: 4 and 8 months (follow-up 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Background: PubMed 16360042Bax JJ, Abraham T, Barold SS, Breithardt OA, Fung JW, Garrigue S, Gorcsan J 3rd, Hayes DL, Kass DA, Knuuti J, Leclercq C, Linde C, Mark DB, Monaghan MJ, Nihoyannopoulos P, Schalij MJ, Stellbrink C, Yu CM. Cardiac resynchronization therapy: Part 1--issues before device implantation. J Am Coll Cardiol. 2005 Dec 20;46(12):2153-67. doi: 10.1016/j.jacc.2005.09.019.
- Background: PubMed 12379577Sogaard P, Egeblad H, Pedersen AK, Kim WY, Kristensen BO, Hansen PS, Mortensen PT. Sequential versus simultaneous biventricular resynchronization for severe heart failure: evaluation by tissue Doppler imaging. Circulation. 2002 Oct 15;106(16):2078-84. doi: 10.1161/01.cir.0000034512.90874.8e.
- Background: PubMed 16476852Bleeker GB, Kaandorp TA, Lamb HJ, Boersma E, Steendijk P, de Roos A, van der Wall EE, Schalij MJ, Bax JJ. Effect of posterolateral scar tissue on clinical and echocardiographic improvement after cardiac resynchronization therapy. Circulation. 2006 Feb 21;113(7):969-76. doi: 10.1161/CIRCULATIONAHA.105.543678. Epub 2006 Feb 13.
- Background: PubMed 15753115Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
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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.
Niels Risum, M.D. principal investigator
University Hospital Gentofte, Department of cardiology
Thomas Fritz Hansen, M.D. study chair
University Hospital Gentofte, department of cardiology
Peter Søgaard, M.D., DMSc. study chair
Gentofte University Hospital, department of cardiology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AV-optimization followed by AV- and VV-optimization and AV- and VV-optimization followed by AV-optimization only. in people with Heart Failure and Ischemic Cardiomyopathy, run by University Hospital, Gentofte, Copenhagen at 2 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 3 inclusion and 10 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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Sweden. 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 Niels Risum, M.D. (+45 39978473, nieris01@geh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responders:Echocardiographic:>/= 10% increase in Left ventricular ejection fraction (LVEF) or >/= 15 % reduction in left ventricular end-systolic volume (LVESV) (time frame: 4 and 8 months, ( follow up- 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955539, which also lists 4 linked publications.
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 6 Oct 2011.