Chronic Pediatric Heart FailureNCT00585065
CRT Pilot Study for Children With Heart Failure
An observational study of Chronic Pediatric Heart Failure, run by University of Utah at 1 site in United States.
Trial summary
To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Chronic Pediatric Heart Failure
- What is being tested?
- CRT device implant
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2016
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Primary care clinic
Who may be able to join
- Chronic and severe heart failure, NYHA class III or IV
- Patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
- Chronic systemic ventricular dysfunction as defined in the protocol.
- Intra ventricular conduction delay defined by spontaneous QRS duration > ULN for age.
- All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
- Signed and dated informed consent.
- Able to receive pectoral or abdominal implant.
Who cannot join
- Suspected acute myocarditis.
- Significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction.
- Acute coronary syndrome.
- Adolescents who are pregnant.
- Patient with BVP device implanted previously.
- Patient has had prior/past heart transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Resynchronization Therapy for Children and Adolescents With Advanced Hearth Failure: A Pilot Study
To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.
- Conditions
- Chronic Pediatric Heart Failure
- Being tested
- CRT device implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT device implantDevice
The purpose of this study is to collect information on patients with chronic heart failure who have already been identified by their physician as candidates for CRT. All tests, including device implantation are standard of care for patients undergoing CRT. The only test involved in this study that is not standard of care is the quality of life questionnaire. Patients who undergo CRT system implant will be followed post-implant (up to 1 week), and at one month, three months, six months and twelve months. The only test involved in this study that is not standard of care is the quality of life questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric and adolescent patients receiving CRT with BVP for treating chronic heart failure | Pediatric and adolescent patients who are receiving cardiac resynchronization therapy with biventricular pacing as a method of treating chronic heart failure. Children of both genders, who are followed in the Division of Pediatric Cardiology at Primary Children's Medical Center, who meet all inclusion and no exclusion criteria are eligible for participation in this clinical study.
No intervention is administered as part of this study. Prospective longitudinal case series study to describe and evaluate clinical and hemodynamic effects of CRT and to identify echocardiographic predictors of positive response to CRT in Group described. Receives: Device: CRT device implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of quality of life information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).
Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always).
Higher scores = Better health related quality of life (HRQOL)
Measured: Within 30 days of CRT implant to 12 months post implant
Collection of survival information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).
Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always).
Higher scores = Better health related quality of life (HRQOL)
Measured: Within 30 days of CRT implant to 12 months post implant
Secondary outcomes (1)
Echocardiographic measurement predictors of positive response to cardiac resynchronization therapy (CRT) in children and adolescent patients according to the American Society of Echocardiography guidelines
Describe the relationship between echocardiographic measures and subject response to CRT
Measured: Within 30 days of CRT implant to 12 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pediatric 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Saarel, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585065
- Sponsor's protocol ID
- 00015291
- Status last verified
- Apr 2021
- First submitted
- 21 Dec 2007
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy for Children and Adolescents With Advanced Hearth Failure: A Pilot Study
- ClinicalTrials.gov ID
- NCT00585065
- Acronym / sponsor ID
- 00015291
- Conditions
- Chronic Pediatric Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Jan 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.
To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric and adolescent patients receiving CRT with BVP for treating chronic heart failure | – | Device: CRT device implantPediatric and adolescent patients who are receiving cardiac resynchronization therapy with biventricular pacing as a method of treating chronic heart failure. Children of both genders, who are followed in the Division of Pediatric Cardiology at Primary Children's Medical Center, who meet all inclusion and no exclusion criteria are eligible for participation in this clinical study. No intervention is administered as part of this study. Prospective longitudinal case series study to describe and evaluate clinical and hemodynamic effects of CRT and to identify echocardiographic predictors of positive response to CRT in Group described. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- Chronic and severe heart failure, NYHA class III or IV
- Patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
- Chronic systemic ventricular dysfunction as defined in the protocol.
- Intra ventricular conduction delay defined by spontaneous QRS duration > ULN for age.
- All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
Key exclusion criteria (6 listed)
- Suspected acute myocarditis.
- Significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction.
- Acute coronary syndrome.
- Adolescents who are pregnant.
- Patient with BVP device implanted previously.
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 |
|---|---|---|
| CRT device implantThe purpose of this study is to collect information on patients with chronic heart failure who have already been identified by their physician as candidates for CRT. All tests, including device implantation are standard of care for patients undergoing CRT. The only test involved in this study that is not standard of care is the quality of life questionnaire. Patients who undergo CRT system implant will be followed post-implant (up to 1 week), and at one month, three months, six months and twelve months. The only test involved in this study that is not standard of care is the quality of life questionnaire. | Device | Pediatric and adolescent patients receiving CRT with BVP for treating chronic heart failure |
Primary outcome
Collection of quality of life information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).
Time frame: Within 30 days of CRT implant to 12 months post implant
Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always). Higher scores = Better health related quality of life (HRQOL)
Collection of survival information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).
Time frame: Within 30 days of CRT implant to 12 months post implant
Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always). Higher scores = Better health related quality of life (HRQOL)
1 secondary outcome
Echocardiographic measurement predictors of positive response to cardiac resynchronization therapy (CRT) in children and adolescent patients according to the American Society of Echocardiography guidelines
Time frame: Within 30 days of CRT implant to 12 months post implant
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 11 May 2023.
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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.
Elizabeth Saarel, MD principal investigator
University of Utah
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 Chronic Pediatric Heart Failure, run by University of Utah 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 7 inclusion and 6 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 11 May 2023. 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?
Collection of quality of life information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification). (time frame: Within 30 days of CRT implant to 12 months post implant). 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 11 May 2023.