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

Phase 4

Terminated

• Conditions: Congestive Heart Failure
• Interventions: Device: Active Cardiac Resynchronization Therapy (CRT)

• Registration Number: NCT00700700
• Lead Sponsor: Queen's University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Study Start: 2008-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-04
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT-ON/CRT-OFF	Active Cardiac Resynchronization Therapy (CRT)	Group initially randomized to CRT-ON, then cross-over to CRT-OFF
CRT-OFF/CRT-ON	Active Cardiac Resynchronization Therapy (CRT)	Group initially randomized to CRT-OFF, then cross-over to CRT-ON

Primary Outcome Measures

Name	Time	Method
Exercise endurance time	6 weeks

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada