Congestive Heart FailurePhase 4NCT00700700
Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)
A Phase 4 study testing Active Cardiac Resynchronization Therapy (CRT) in people with Congestive Heart Failure, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Active Cardiac Resynchronization Therapy (CRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Active Cardiac Resynchronization Therapy (CRT)
- Keywords
- Congestive Heart Failure, Cardiac Resynchronization Therapy, Dyspnea, Exercise Tolerance
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cardiac Resynchronization Therapy (CRT)Device
Also called Received one of the above devices used in 2007-2008 at Kingston General Hospital.
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:
- Ovatio CRT 6750
| Study group | Role | What they receive |
|---|---|---|
| CRT-ON/CRT-OFF | Active comparator | Group initially randomized to CRT-ON, then cross-over to CRT-OFF Receives: Device: Active Cardiac Resynchronization Therapy (CRT) |
| CRT-OFF/CRT-ON | Active comparator | Group initially randomized to CRT-OFF, then cross-over to CRT-ON Receives: Device: Active Cardiac Resynchronization Therapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise endurance time
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Stopped due to an inability to recruit eligible subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Chris M. Parker, MD, MSc, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700700
- Sponsor's protocol ID
- DMED-1082-07
- Status last verified
- Jul 2011
- First submitted
- 16 May 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiac Resynchronization Therapy on Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00700700
- Acronym / sponsor ID
- DMED-1082-07
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Cardiac Resynchronization Therapy, Dyspnea, Exercise Tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to an inability to recruit eligible subjects.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-ON/CRT-OFF | Active comparator | Device: Active Cardiac Resynchronization Therapy (CRT)Group initially randomized to CRT-ON, then cross-over to CRT-OFF |
| CRT-OFF/CRT-ON | Active comparator | Device: Active Cardiac Resynchronization Therapy (CRT)Group initially randomized to CRT-OFF, then cross-over to CRT-ON |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinically stable
- being considered for implantation of biventricular pacemaker for CRT
- LVEF <35%
- QRS duration >120 msec
- NYHA III-IV functional class
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Cardiac Resynchronization Therapy (CRT)Also: Received one of the above devices used in 2007-2008 at Kingston General Hospital.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 | Device | CRT-OFF/CRT-ON, CRT-ON/CRT-OFF |
Primary outcome
Exercise endurance time
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Stopped due to an inability to recruit eligible subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris M. Parker, MD, MSc principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Active Cardiac Resynchronization Therapy (CRT) in people with Congestive Heart Failure, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Stopped due to an inability to recruit eligible subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise endurance time (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.