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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Niels Risum, M.D. contact

+45 39978473

nieris01@geh.regionh.dk

Thomas Fritz Hansen, M.D. contact

+45 39773977

THHAN@geh.regionh.dk

2 sites in 2 countries

Denmark1 site, 1 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

    Recruiting

Other trials in Denmark

Sweden1 site, 1 recruiting

  • University Hospital Lund

    Lund, Lund, 221 85

    Rasmus Borgquist, MD, PhD, +46 70-4057350, rasmus.borgquist@med.lu.se

    Rasmus Borgquist, MD, PhD

    Recruiting

Other trials in Sweden

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

  1. Mechanical dyssynchrony can predict response to CRT. b. Measures of mechanical dyssynchrony is related to myocardial viability and conduction.
  2. Individual optimization based on conduction times will increase benefit to CRT. b. The effect of adding VV-optimization is related to myocardial viability.
  3. > 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.
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 groups in NCT00955539
Study groupRoleWhat they receive
CRT group 1Active comparatorNot described
Receives: Device: AV-optimization followed by AV- and VV-optimization
CRT group 2Active comparatorNot 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.

  1. 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)

  1. 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)

  2. 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.

  1. First posted10 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2012 (estimated)
  4. Study completionJun 2013 (estimated)

Resources

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)
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 16360042

  • Sogaard 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 12379577

  • Bleeker 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 16476852

  • Cleland 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

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.

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