Heart Failure - NYHA II - IVDIRECTNCT01097733
Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy
An observational study of Heart Failure - NYHA II - IV and Wide QRS Complex, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Cardiac Resynchronization Therapy (CRT) is a widely accepted treatment that has led to improved clinical outcomes for patients with refractory congestive heart failure (CHF), systolic dysfunction, and wide QRS duration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure - NYHA II - IV, Wide QRS Complex
- What is being tested?
- Randomization of Pre-knowledge of CT coronary venography
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2012
- 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: Outpatient or inpatient heart failure patients scheduled for CRT implantation
Who may be able to join
- Older than 18 years of age
- Ability to provide informed consent
- Planned CRT implantation
- NYHA Functional Class II-IV heart failure
- Echo Ejection Fraction less than or equal to 35%
- QRS duration greater than or equal to 120 ms
- Normal or mildly reduced kidney function (estimated serum creatinine less than or equal to 1.5 mg/dL or less than or equal to 1.3 mg/dL for diabetic subjects on metformin
- For diabetic subjects on glucophage (metformin) they will be required to stop glucophage (metformin) for at least 48 hours after the administration of contrast.
Who cannot join
- Known allergy to iodine or iodinated contrast
- Chronic persistent atrial fibrillation
- Pregnancy or unknown pregnancy status
- Subjects on glucophage (metformin) therapy that are unable or unwilling to discontinue therapy for 48 hours after CT scan
- Known inadequate venous access for appropriate IV caliber placement
- Iodinated contrast administration within the past 48 hours
- Subjects who cannot hold their breath for 10-15 seconds
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Cardiac Resynchronization Therapy (CRT) is a widely accepted treatment that has led to improved clinical outcomes for patients with refractory congestive heart failure (CHF), systolic dysfunction, and wide QRS duration. However, it requires implantation of an expensive device ($30,000) and about 1/3 of patients do not have clinical improvement. Inadequate amounts of LV dyssynchrony or suboptimal lead placement may limit clinical response. Dual-Source computed tomography (DSCT) allows for subtle detection during myocardial contraction for assessing LV dyssynchrony, and can also assess coronary venous anatomy and scar burden. Thus DSCT may be the ideal noninvasive modality to predict response to CRT.
- Conditions
- Heart Failure - NYHA II - IV, Wide QRS Complex
- Being tested
- Randomization of Pre-knowledge of CT coronary venography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization of Pre-knowledge of CT coronary venographyOther
| Study group | Role | What they receive |
|---|---|---|
| Pre-procedural cardiac CT | CRT patients will undergo pre-procedural cardiac CT to assess for dyssynchrony, scar, and coronary venous anatomy. The CT venogram will be randomize to pre-knowledge to implanting physician or blinded. The CT dyssynchrony and scar assessment will remain blinded to caregivers and patients. Receives: Other: Randomization of Pre-knowledge of CT coronary venography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response to CRT
The clinical response to CRT will be adjudicated by two experienced cardiologists taking into account left ventricular ejection fraction, NYHA functional class, and patient global assessment score.
Measured: 6 months post implantation of CRT
Secondary outcomes (2)
Major adverse cardiovascular events (MACE)
MACE defined as composite endpoints of death, cardiac transplant, left ventricular assist device, and HF hospitalization
Measured: 2 years
Secondary endpoints
Change in NYHA Functional Class, Echo volumes and ejection fraction, Minnesota Quality of Life score, 6-minute walk distance, NT-proBNP levels, and hospitalization at 6 months
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 posted2 Apr 2010 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure - NYHA II - IVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Abbott Medical Devices
- Responsible party
- Principal investigator, Jagmeet Singh, Massachusetts General Hospital
- Investigators
- Jagmeet P Singh, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097733
- Sponsor's protocol ID
- 2008P000555
- Other IDs
- 1K23HL098370
- Acronym
- DIRECT
- Status last verified
- Sep 2022
- First submitted
- 25 Mar 2010
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Truong QA, Singh JP, Cannon CP, Sarwar A, Nasir K, Auricchio A, Faletra FF, Sorgente A, Conca C, Moccetti T, Handschumacher M, Brady TJ, Hoffmann U. Quantitative analysis of intraventricular dyssynchrony using wall thickness by multidetector computed tomography. JACC Cardiovasc Imaging. 2008 Nov;1(6):772-81. doi: 10.1016/j.jcmg.2008.07.014.
PubMed 19212461Galand V, Ghoshhajra B, Szymonifka J, Das S, Orencole M, Barre V, Martins RP, Leclercq C, Hung J, Truong QA, Singh JP. Left ventricular wall thickness assessed by cardiac computed tomography and cardiac resynchronization therapy outcomes. Europace. 2020 Mar 1;22(3):401-411. doi: 10.1093/europace/euz322.
PubMed 31865389Truong QA, Szymonifka J, Picard MH, Thai WE, Wai B, Cheung JW, Heist EK, Hoffmann U, Singh JP. Utility of dual-source computed tomography in cardiac resynchronization therapy-DIRECT study. Heart Rhythm. 2018 Aug;15(8):1206-1213. doi: 10.1016/j.hrthm.2018.03.020. Epub 2018 Mar 20.
PubMed 29572087
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Source Computed Tomography to Improve Prediction of Response to Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01097733
- Acronym / sponsor ID
- DIRECT / 2008P000555
- Conditions
- Heart Failure - NYHA II - IV, Wide QRS Complex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Abbott Medical Devices
- Study start
- Feb 2009 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Apr 2010 (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.
Cardiac Resynchronization Therapy (CRT) is a widely accepted treatment that has led to improved clinical outcomes for patients with refractory congestive heart failure (CHF), systolic dysfunction, and wide QRS duration. However, it requires implantation of an expensive device ($30,000) and about 1/3 of patients do not have clinical improvement. Inadequate amounts of LV dyssynchrony or suboptimal lead placement may limit clinical response. Dual-Source computed tomography (DSCT) allows for subtle detection during myocardial contraction for assessing LV dyssynchrony, and can also assess coronary venous anatomy and scar burden. Thus DSCT may be the ideal noninvasive modality to predict response to CRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-procedural cardiac CT | – | Other: Randomization of Pre-knowledge of CT coronary venographyCRT patients will undergo pre-procedural cardiac CT to assess for dyssynchrony, scar, and coronary venous anatomy. The CT venogram will be randomize to pre-knowledge to implanting physician or blinded. The CT dyssynchrony and scar assessment will remain blinded to caregivers and patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient or inpatient heart failure patients scheduled for CRT implantation
Key inclusion criteria (8 listed)
- Older than 18 years of age
- Ability to provide informed consent
- Planned CRT implantation
- NYHA Functional Class II-IV heart failure
- Echo Ejection Fraction less than or equal to 35%
Key exclusion criteria (7 listed)
- Known allergy to iodine or iodinated contrast
- Chronic persistent atrial fibrillation
- Pregnancy or unknown pregnancy status
- Subjects on glucophage (metformin) therapy that are unable or unwilling to discontinue therapy for 48 hours after CT scan
- Known inadequate venous access for appropriate IV caliber placement
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 |
|---|---|---|
| Randomization of Pre-knowledge of CT coronary venography | Other | Pre-procedural cardiac CT |
Primary outcome
Clinical Response to CRT
Time frame: 6 months post implantation of CRT
The clinical response to CRT will be adjudicated by two experienced cardiologists taking into account left ventricular ejection fraction, NYHA functional class, and patient global assessment score.
2 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 2 years
Secondary endpoints
Time frame: 6 months
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 3 Oct 2022.
- Background: PubMed 19212461Truong QA, Singh JP, Cannon CP, Sarwar A, Nasir K, Auricchio A, Faletra FF, Sorgente A, Conca C, Moccetti T, Handschumacher M, Brady TJ, Hoffmann U. Quantitative analysis of intraventricular dyssynchrony using wall thickness by multidetector computed tomography. JACC Cardiovasc Imaging. 2008 Nov;1(6):772-81. doi: 10.1016/j.jcmg.2008.07.014.
- Derived from this study: PubMed 31865389Galand V, Ghoshhajra B, Szymonifka J, Das S, Orencole M, Barre V, Martins RP, Leclercq C, Hung J, Truong QA, Singh JP. Left ventricular wall thickness assessed by cardiac computed tomography and cardiac resynchronization therapy outcomes. Europace. 2020 Mar 1;22(3):401-411. doi: 10.1093/europace/euz322.
- Derived from this study: PubMed 29572087Truong QA, Szymonifka J, Picard MH, Thai WE, Wai B, Cheung JW, Heist EK, Hoffmann U, Singh JP. Utility of dual-source computed tomography in cardiac resynchronization therapy-DIRECT study. Heart Rhythm. 2018 Aug;15(8):1206-1213. doi: 10.1016/j.hrthm.2018.03.020. Epub 2018 Mar 20.
Related trials for Heart Failure - NYHA II - IV
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Recruiting
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Heart Failure - NYHA II - IV
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
RecruitingPhase 3
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
Heart Failure
Recruiting
Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)
Heart Failure, Heart Failure - NYHA II - IV
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.
Jagmeet P Singh, MD, PhD principal investigator
Massachusetts General Hospital
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 - NYHA II - IV and Wide QRS Complex, run by Massachusetts General Hospital 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 8 inclusion and 7 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 3 Oct 2022. 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?
Clinical Response to CRT (time frame: 6 months post implantation of CRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097733, which also lists 3 linked publications.
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 3 Oct 2022.