Heart FailureNCT01466621
Response to Cardiac Resynchronization Therapy of Previously Right Ventricular Paced Heart Failure Patients
An observational study of Heart Failure and Pacing Induced Dyssynchrony, run by Allina Health System at 1 site in United States.
Trial summary
The present proposal is designed to investigate the response to CRT in patients who were previously paced from the right ventricle (RV). The negative physiologic and structural changes associated with chronic RV pacing are well documented, but patient response following upgrade to CRT after chronic RV pacing has not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pacing Induced Dyssynchrony
- How many people
- 743 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective review of patients receiving CRT at United Heart \& Vascular Clinic between 2003 and 2009.
Who may be able to join
- Received a CRT device between 2003 and 2009 at United Heart \& Vascular Clinic
- QRS duration > 120 msec
- Pre-CRT ejection fraction =< 35%
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
United Heart & Vascular Clinic
Saint Paul, Minnesota, 55102
About this study
The present proposal is designed to investigate the response to CRT in patients who were previously paced from the right ventricle (RV). The negative physiologic and structural changes associated with chronic RV pacing are well documented, but patient response following upgrade to CRT after chronic RV pacing has not been well characterized in a large cohort.
Read the detailed description
The RV apex has historically been used as the site for ventricular pacing in cases of sinus node dysfunction or atrioventricular block because of its relatively accessible location for lead implantation. Initial studies showed RV pacing improved symptoms, exercise capacity, quality of life, and survival in these patients.11-13 However, more recent studies have illustrated that chronic RV pacing may actually impair LV systolic function and increase the risks of heart failure, hospitalization, and death in some patients.
The primary hypothesis is that patients upgraded to CRT from a RV pacemaker respond better than those receiving CRT as a first time device. To test this hypothesis the investigators will compare changes in cardiac size and function, and hospitalization and survival rates between the two patient groups.
The second hypothesis will investigate whether changes in septal dyssynchrony are correlated with changes in ejection fraction in previously RV paced patients. The investigators believe that the patients with the most improvement in septal dyssynchrony due to RV pacing will see the greatest improvement in LV function following upgrade to CRT. A significant correlation between change in IM-S and change in EF will support the hypothesis.
- Conditions
- Heart Failure, Pacing Induced Dyssynchrony
- Keywords
- cardiac resynchronization therapy, heart failure, mortality
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Previously RV Paced | Patients who were RV paced prior to receiving a cardiac resynchronization therapy device. | |
| Non-Previously RV Paced | Patients who received a CRT device without being previously RV paced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Retrospectively measure the time in days from device implant to death, if applicable.
Measured: Average of 4 years
Cardiovascular Hospitalization
Retrospectively measure the time in days from device implant to hospitalization, if applicable.
Measured: Average of 4 years
Secondary outcomes (1)
Change in ejection fraction
A measure of cardiac performance.
Measured: Approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Alan J Bank, MD, Principal investigator, United Heart & Vascular Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466621
- Sponsor's protocol ID
- ISRCRM110009(Boston Sci Corp)
- Status last verified
- Feb 2016
- First submitted
- 2 Nov 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Cardiac Resynchronization Therapy of Previously Right Ventricular Paced Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01466621
- Acronym / sponsor ID
- ISRCRM110009(Boston Sci Corp)
- Conditions
- Heart Failure, Pacing Induced Dyssynchrony
- Keywords
- cardiac resynchronization therapy, heart failure, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Nov 2011 (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.
The present proposal is designed to investigate the response to CRT in patients who were previously paced from the right ventricle (RV). The negative physiologic and structural changes associated with chronic RV pacing are well documented, but patient response following upgrade to CRT after chronic RV pacing has not been well characterized in a large cohort.
Detailed description
The RV apex has historically been used as the site for ventricular pacing in cases of sinus node dysfunction or atrioventricular block because of its relatively accessible location for lead implantation. Initial studies showed RV pacing improved symptoms, exercise capacity, quality of life, and survival in these patients.11-13 However, more recent studies have illustrated that chronic RV pacing may actually impair LV systolic function and increase the risks of heart failure, hospitalization, and death in some patients.
The primary hypothesis is that patients upgraded to CRT from a RV pacemaker respond better than those receiving CRT as a first time device. To test this hypothesis the investigators will compare changes in cardiac size and function, and hospitalization and survival rates between the two patient groups.
The second hypothesis will investigate whether changes in septal dyssynchrony are correlated with changes in ejection fraction in previously RV paced patients. The investigators believe that the patients with the most improvement in septal dyssynchrony due to RV pacing will see the greatest improvement in LV function following upgrade to CRT. A significant correlation between change in IM-S and change in EF will support the hypothesis.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously RV Paced | – | –Patients who were RV paced prior to receiving a cardiac resynchronization therapy device. |
| Non-Previously RV Paced | – | –Patients who received a CRT device without being previously RV paced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective review of patients receiving CRT at United Heart \& Vascular Clinic between 2003 and 2009.
Key inclusion criteria (3 listed)
- Received a CRT device between 2003 and 2009 at United Heart \& Vascular Clinic
- QRS duration > 120 msec
- Pre-CRT ejection fraction =< 35%
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death from any cause
Time frame: Average of 4 years
Retrospectively measure the time in days from device implant to death, if applicable.
Cardiovascular Hospitalization
Time frame: Average of 4 years
Retrospectively measure the time in days from device implant to hospitalization, if applicable.
1 secondary outcome
Change in ejection fraction
Time frame: Approximately one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Alan J Bank, MD principal investigator
United Heart & Vascular Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Pacing Induced Dyssynchrony, run by Allina Health System at 1 site in United States.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 24 Feb 2016. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death from any cause (time frame: Average of 4 years). The study lists 2 primary outcomes in all. 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 24 Feb 2016.