Heart FailureFAST DOGSNCT02510677
Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT
A study testing myocardial perfusion scintigraphy in people with Heart Failure, run by University Hospital, Caen at 1 site in France.
Trial summary
The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- myocardial perfusion scintigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jan 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patient with heart failure on optimal medical therapy and targeted for cardiac resynchronization therapy according to current recommendations;
- Age over 18 years
- Clinically stable (without hospitalization for heart failure in the last month)
- Sinus rhythm
- Social security insurance
- Signed consent form
Who cannot join
- Recent history (less than 21 days) of acute coronary syndrome or unstable angina;
- Recent history (less than 1 month) of acute heart failure;
- Right bundle branch block;
- Irregular heart rate;
- Double-chamber cardiac pacemaker
- Patients previously implanted with a single-chamber cardioverter-defibrillator must have at least 99 percent of unstimulated QRS.
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- Countraindication to dobutamine therapy;
- Valvular heart disease, congenital heart disease, hypertrophic cardiomyopathy;
- Significant Ventricular arrhythmias;
- Hypertension (upper than 160/100 mmHg);
- Pregnant, breastfeeding or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.
Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.
- Conditions
- Heart Failure
- Being tested
- myocardial perfusion scintigraphy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial perfusion scintigraphyOther
| Study group | Role | What they receive |
|---|---|---|
| myocardial perfusion scintigraphy | Other | Low-dose dobutamine gated SPECT and CZT camera for the assessment of parameters of left ventricular dyssynchrony in heart failure patients eligible for the implantation of a cardiac resynchronization device. Receives: Other: myocardial perfusion scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
measures of dyssynchrony parameters
The primary endpoint is reproducible quantitative measures of dyssynchrony parameters between two successive acquisitions basal (entropy, bandwidth, standard deviation phase histogram).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2017
- Study completionJan 2017
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.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510677
- Sponsor's protocol ID
- 12-176
- Acronym
- FAST DOGS
- Status last verified
- Jan 2017
- First submitted
- 22 Jul 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT
- ClinicalTrials.gov ID
- NCT02510677
- Acronym / sponsor ID
- FAST DOGS / 12-176
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Jul 2015 (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 prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.
Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myocardial perfusion scintigraphy | Other | Other: myocardial perfusion scintigraphyLow-dose dobutamine gated SPECT and CZT camera for the assessment of parameters of left ventricular dyssynchrony in heart failure patients eligible for the implantation of a cardiac resynchronization device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with heart failure on optimal medical therapy and targeted for cardiac resynchronization therapy according to current recommendations;
- Age over 18 years
- Clinically stable (without hospitalization for heart failure in the last month)
- Sinus rhythm
- Social security insurance
Key exclusion criteria (11 listed)
- Recent history (less than 21 days) of acute coronary syndrome or unstable angina;
- Recent history (less than 1 month) of acute heart failure;
- Right bundle branch block;
- Irregular heart rate;
- Double-chamber cardiac pacemaker
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 |
|---|---|---|
| myocardial perfusion scintigraphy | Other | myocardial perfusion scintigraphy |
Primary outcome
measures of dyssynchrony parameters
Time frame: baseline
The primary endpoint is reproducible quantitative measures of dyssynchrony parameters between two successive acquisitions basal (entropy, bandwidth, standard deviation phase histogram).
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 1 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myocardial perfusion scintigraphy in people with Heart Failure, run by University Hospital, Caen at 1 site in France.
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 6 inclusion and 11 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 1 Feb 2017. 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 France. 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?
measures of dyssynchrony parameters (time frame: baseline). 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 1 Feb 2017.