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

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CRT-ON/CRT-OFF

Group initially randomized to CRT-ON, then cross-over to CRT-OFF

Group Type ACTIVE_COMPARATOR

Active Cardiac Resynchronization Therapy (CRT)

Intervention Type DEVICE

Initiation of active biventricular pacing/cardiac resynchronization therapy

Devices by Medtronic:

1. Insync Sentry 7298 \& 7299
2. Concerto C174 ASK (Most frequently implanted)
3. Insync III 8042 (PM)

Devices by Guidant/Boston Scientific:

1. Contak Renewal 4 H190 \& H199
2. Contak Renewal 3 H127

Devices by ELA/Sorin:

1\. Ovatio CRT 6750

CRT-OFF/CRT-ON

Group initially randomized to CRT-OFF, then cross-over to CRT-ON

Group Type ACTIVE_COMPARATOR

Active Cardiac Resynchronization Therapy (CRT)

Intervention Type DEVICE

Initiation of active biventricular pacing/cardiac resynchronization therapy

Devices by Medtronic:

1. Insync Sentry 7298 \& 7299
2. Concerto C174 ASK (Most frequently implanted)
3. Insync III 8042 (PM)

Devices by Guidant/Boston Scientific:

1. Contak Renewal 4 H190 \& H199
2. Contak Renewal 3 H127

Devices by ELA/Sorin:

1\. Ovatio CRT 6750

Interventions

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Active Cardiac Resynchronization Therapy (CRT)

Initiation of active biventricular pacing/cardiac resynchronization therapy

Devices by Medtronic:

1. Insync Sentry 7298 \& 7299
2. Concerto C174 ASK (Most frequently implanted)
3. Insync III 8042 (PM)

Devices by Guidant/Boston Scientific:

1. Contak Renewal 4 H190 \& H199
2. Contak Renewal 3 H127

Devices by ELA/Sorin:

1\. Ovatio CRT 6750

Intervention Type DEVICE

Other Intervention Names

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Received one of the above devices used in 2007-2008 at Kingston General Hospital.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No