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Viability and Cardiac Resynchronization Therapy

NCT ID: NCT00955539

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Heart Failure Ischemic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CRT group 1

Group Type ACTIVE_COMPARATOR

AV-optimization followed by AV- and VV-optimization

Intervention Type DEVICE

Patients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months.

CRT group 2

Group Type ACTIVE_COMPARATOR

AV- and VV-optimization followed by AV-optimization only.

Intervention Type DEVICE

Patients are AV- and VV-optimized the first 4 months,then AV-optimized the next 4 months.

Interventions

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AV-optimization followed by AV- and VV-optimization

Patients are AV-optimized the first 4 months,then AV- and VV-optimized the next 4 months.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Pregnancy
* Unstable angina pectoris
* Chronical atrial fibrillation
* Severe valvular disease
* Dementia or mental retardation
* Severe claustrophobia
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Niels Risum

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niels Risum, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Gentofte, Department of cardiology

Thomas Fritz Hansen, M.D.

Role: STUDY_CHAIR

University Hospital Gentofte, department of cardiology

Peter Søgaard, M.D., DMSc.

Role: STUDY_CHAIR

Gentofte University Hospital, department of cardiology

Rasmus Borgquist, MD, PhD

Role: STUDY_CHAIR

University Hospital Lund

Niels E Bruun, MD, DMSc

Role: STUDY_CHAIR

Gentofte University Hospital, department of cardiology

Locations

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Gentofte University Hospital

Hellerup, , Denmark

Site Status RECRUITING

University Hospital Lund

Lund, Lund, Sweden

Site Status RECRUITING

Countries

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Denmark Sweden

Central Contacts

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Niels Risum, M.D.

Role: CONTACT

[email protected]
+45 39978473

Thomas Fritz Hansen, M.D.

Role: CONTACT

[email protected]
+45 39773977

Facility Contacts

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Niels Risum, M.D.

Role: primary

[email protected]
+45 39978473

Thomas Fritz Hansen, M.D.

Role: backup

[email protected]
+45 39773977

Rasmus Borgquist, MD, PhD

Role: primary

[email protected]
+46 70-4057350

References

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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.

Reference Type BACKGROUND
PMID: 16360042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12379577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16476852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15753115 (View on PubMed)

Other Identifiers

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H-B-2009-057

Identifier Type: -

Identifier Source: org_study_id