Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF) - Full Text View

Sponsored by:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00700700

Purpose

A new therapy for patients with advanced heart failure (HF) involves the implantation of a specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to restore the synchronized contraction of the ventricular chambers of the heart. In some people, CRT improves exertional breathlessness and allows them to exercise for longer periods. However, to date, the mechanisms by which CRT improves symptoms and exercise tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and pulmonary function testing to explore these mechanisms in greater detail.

Condition	Intervention	Phase
Congestive Heart Failure	Device: Active Cardiac Resynchronization Therapy (CRT)	Phase IV

MedlinePlus related topics: Breathing Problems Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Crossover Assignment
Official Title:	Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure

Further study details as provided by Queen's University:

Primary Outcome Measures:

Exercise endurance time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CRT-ON/CRT-OFF: Active Comparator Group initially randomized to CRT-ON, then cross-over to CRT-OFF	Device: Active Cardiac Resynchronization Therapy (CRT) Initiation of active biventricular pacing/cardiac resynchronization therapy Devices by Medtronic: Insync Sentry 7298 & 7299 Concerto C174 ASK (Most frequently implanted) Insync III 8042 (PM) Devices by Guidant/Boston Scientific: Contak Renewal 4 H190 & H199 Contak Renewal 3 H127 Devices by ELA/Sorin: 1. Ovatio CRT 6750
CRT-OFF/CRT-ON: Active Comparator Group initially randomized to CRT-OFF, then cross-over to CRT-ON	Device: Active Cardiac Resynchronization Therapy (CRT) Initiation of active biventricular pacing/cardiac resynchronization therapy Devices by Medtronic: Insync Sentry 7298 & 7299 Concerto C174 ASK (Most frequently implanted) Insync III 8042 (PM) Devices by Guidant/Boston Scientific: Contak Renewal 4 H190 & H199 Contak Renewal 3 H127 Devices by ELA/Sorin: 1. Ovatio CRT 6750

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

clinically stable
being considered for implantation of biventricular pacemaker for CRT
LVEF <35%
QRS duration >120 msec
NYHA III-IV functional class
optimized pharmacologic management of CHF
no recent (<1 month) episodes of decompensated CHF

Exclusion Criteria:

inability to perform cycle ergometry or comply with testing
uncontrolled ischemic heart disease
coronary revascularization within 3 months of study entry
concurrent primary lung disease
current use of ambulatory oxygen
rhythm other than sinus
dependency on pacemaker therapy as a consequence of bradyarrhythmias
severe valvulopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700700

Contacts

Contact: Chris M Parker, MD MSc	613-548-2384	parkerc@queensu.ca
Contact: Mariam N Harrison, MD	613-650-6210	mariam.harrison@utoronto.ca

Locations

Canada, Ontario
Kingston General Hospital	Recruiting
Kingston, Ontario, Canada, K7L 3N6
Principal Investigator: Chris M. Parker, MD MSc

Sponsors and Collaborators

Queen's University

Investigators

Principal Investigator:

Chris M. Parker, MD, MSc

Queen's University

More Information

Responsible Party:	Queen's University ( Dr. Chris M. Parker, Assistant Professor )
Study ID Numbers:	DMED-1082-07
Study First Received:	May 16, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00700700
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

Congestive Heart Failure
Cardiac Resynchronization Therapy
Dyspnea
Exercise Tolerance

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Dyspnea

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009