Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure |
- Exercise endurance time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 2 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CRT-ON/CRT-OFF
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:
Devices by Guidant/Boston Scientific:
Devices by ELA/Sorin: 1. Ovatio CRT 6750 Other Name: Received one of the above devices used in 2007-2008 at Kingston General Hospital.
|
|
Active Comparator: CRT-OFF/CRT-ON
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:
Devices by Guidant/Boston Scientific:
Devices by ELA/Sorin: 1. Ovatio CRT 6750 Other Name: Received one of the above devices used in 2007-2008 at Kingston General Hospital.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| Responsible Party: | Dr. Chris M. Parker, Assistant Professor, Queen's University |
| ClinicalTrials.gov Identifier: | NCT00700700 History of Changes |
| Other Study ID Numbers: | DMED-1082-07 |
| Study First Received: | May 16, 2008 |
| Last Updated: | July 4, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Queen's University:
|
Congestive Heart Failure Cardiac Resynchronization Therapy Dyspnea Exercise Tolerance |
Additional relevant MeSH terms:
|
Dyspnea Heart Failure Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013