Viability and Cardiac Resynchronization Therapy

NCT00955539 | Unknown DMC

• 1 other identifier: H-B-2009-057
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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 implant seems to be important. In this study, these factors are further investigated.

Conditions

Heart Failure; Ischemic Cardiomyopathy

Keywords

Heart Failure; Cardiac resynchronization therapy; Optimization; Viability; Mechanical dyssynchrony

Outcome Measures

Primary Outcomes (1)

• Responders:Echocardiographic:>/= 10% increase in Left ventricular ejection fraction (LVEF) or >/= 15 % reduction in left ventricular end-systolic volume (LVESV)

  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

  4 and 8 months (follow-up after 2 years)

• Clinical: >/= 25% increase in 6-min walk test or >/= 1 reduction in NYHA-class

  4 and 8 months (follow-up 2 years)

Study Arms (2)

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.

Interventions

AV-optimization followed by AV- and VV-optimization DEVICE

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

CRT group 1

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.

CRT group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Lund University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Gentofte University Hospital

Hellerup, 2900, Denmark

RECRUITING

University Hospital Lund

Lund, Lund, 221 85, Sweden

RECRUITING

Related Publications (4)

• 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.

  PMID: 16360042 BACKGROUND

• 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.

  PMID: 12379577 BACKGROUND

• 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.

  PMID: 16476852 BACKGROUND

• 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.

  PMID: 15753115 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Niels Risum, M.D.

  University Hospital Gentofte, Department of cardiology

  PRINCIPAL INVESTIGATOR

• Thomas Fritz Hansen, M.D.

  University Hospital Gentofte, department of cardiology

  STUDY CHAIR

• Peter Søgaard, M.D., DMSc.

  Gentofte University Hospital, department of cardiology

  STUDY CHAIR

• Rasmus Borgquist, MD, PhD

  University Hospital Lund

  STUDY CHAIR

• Niels E Bruun, MD, DMSc

  Gentofte University Hospital, department of cardiology

  STUDY CHAIR

Central Study Contacts

Niels Risum, M.D.

CONTACT

+45 39978473; nieris01@geh.regionh.dk

Thomas Fritz Hansen, M.D.

CONTACT

+45 39773977; THHAN@geh.regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

SE (1); DK (1)