Sympathetic InnervationPET-CRTNCT00567645
Sympathetic Innervation of the Heart and Cardiac Resynchronization Therapy(CRT)
An observational study of Sympathetic Innervation and Chronic Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sympathetic Innervation, Chronic Heart Failure
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2007to not given
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic heart failure patients with CRT
Who may be able to join
- Indication for CRT
- Stable optimal medication
- Non ischemic cardiomyopathy
Who cannot join
- Age less then 18 years
- Previous CRT
- Clinically relevant valvular heart disease or coronary artery disease
- Acute or chronic infection
- Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism
- Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg
Show all 9Show fewer
- A concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extra cardiac disease or M. Parkinson) or is unlikely to comply with the protocol
- Participation to a previous protocol involving radioactivity in the past year
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB
About this study
Official title: Identification of the Role of Sympathetic Innervation in Heart Failure Patients Treated With Cardiac Resynchronization Therapy. A Pilot Study
The purpose of this study is to assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation.
- Conditions
- Sympathetic Innervation, Chronic Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
sympathetic innervation in patients with chronic heart failure (CHF)
Measured: 6 months
Secondary outcomes (1)
NYHA class Echocardiographic parameters: LVEDD, LVESD, LVEF, LVESV,IVMD, and septal to lateral delay Hospitalization for heart failure Maximal oxygen consumption NT pro-BNP changes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sympathetic InnervationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I.C. Van Gelder, University Medical Center Groningen
- Investigators
- Isabelle C. Van Gelder, Prof, Principal investigator, University Medical Center Groningen, departmen cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567645
- Sponsor's protocol ID
- 16716
- Acronym
- PET-CRT
- Status last verified
- May 2016
- First submitted
- 4 Dec 2007
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Role of Sympathetic Innervation in Heart Failure Patients Treated With Cardiac Resynchronization Therapy. A Pilot Study
- ClinicalTrials.gov ID
- NCT00567645
- Acronym / sponsor ID
- PET-CRT / 16716
- Conditions
- Sympathetic Innervation, Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jul 2007
- First posted
- 5 Dec 2007 (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 purpose of this study is to assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic heart failure patients with CRT
Key inclusion criteria (3 listed)
- Indication for CRT
- Stable optimal medication
- Non ischemic cardiomyopathy
Key exclusion criteria (9 listed)
- Age less then 18 years
- Previous CRT
- Clinically relevant valvular heart disease or coronary artery disease
- Acute or chronic infection
- Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism
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
sympathetic innervation in patients with chronic heart failure (CHF)
Time frame: 6 months
1 secondary outcome
NYHA class Echocardiographic parameters: LVEDD, LVESD, LVEF, LVESV,IVMD, and septal to lateral delay Hospitalization for heart failure Maximal oxygen consumption NT pro-BNP changes
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
Isabelle C. Van Gelder, Prof principal investigator
University Medical Center Groningen, departmen cardiology
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 Sympathetic Innervation and Chronic Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
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 9 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: withdrawn, as of the sponsor's last update on 13 May 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 Netherlands. 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 was withdrawn before enrolling participants, so there are no results.
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?
sympathetic innervation in patients with chronic heart failure (CHF) (time frame: 6 months). 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 13 May 2016.