Heart FailureCRT-LVADNCT02169076
Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients
A study testing Cardiac Resynchronization Therapy in people with Heart Failure, run by University of Louisville at 1 site in United States.
Trial summary
Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure patients with previously implanted Bi-Ventricular pacemaker / defibrillator, and continuous flow LVAD (Heart Mate II® or HeartWare®)
- The LVAD must be implanted between 8 weeks and 18 months prior to enrollment
- Patients should be at least 3 weeks post discharge from the LVAD implant hospitalization
Who cannot join
- Severe decompensated right ventricular failure defined as requiring any of the following:
- Hospitalization for heart failure within last 30 days
- Need for inotropic infusion for > 48h within the last 14 days
- Increase of > 100% diuretic dose within last 14 days
- Severe aortic regurgitation documented by echocardiography or cardiac catheterization
- Stage IV or greater kidney disease (GFR < 30 mL/min/1.73 m2)
Show all 11Show fewer
- Active infection (not including controlled chronic driveline infection on suppressive antibiotic therapy)
- Biventricular pacing < 90 % of time due to uncontrolled arrhythmias
- LVAD malfunction
- Inability to follow study protocol
- Non-functional LV lead (i.e. high capture threshold that cannot be corrected with programming changes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Resynchronization Therapy in Patients With Left Ventricular Assist Devices
Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy (CRT) aims to restore the synchronized contraction of the heart and has proven to be beneficial for improving ejection fraction of both right and left ventricle as well as quality of life in selected heart failure patients. The role of CRT in patients with LVADs is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function in LVAD patients and improve their quality-of-life.
The specific questions that this study aims to answer are:
Read more
- What are the effects of CRT on the function of the non-supported right ventricle in patients with an implanted LVAD?
- Can the effects of CRT on cardiac function positively impact quality-of-life and exercise capacity in LVAD recipients?
In this study patients with a previously implanted CRT device, who later receives an LVAD, will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients will be followed for an 8-week period, and then switched over to the opposite CRT status. The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart function will be assessed with comprehensive echocardiographic studies during the CRT "on" and CRT "off" periods. Quality-of-life and exercise capacity will be assessed with a standardized questionnaire and a 6-Minute Walk Test.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy
- Keywords
- Ventricular Assist Device, Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
The cardiac resynchronization therapy of the ICD/Pacemaker device of the patients enrolled in the study will be programed under a standardized protocol and enabled or disabled in a crossover fashion during the study.
| Study group | Role | What they receive |
|---|---|---|
| CRT-On | Active comparator | Cardiac Resynchronization Therapy enabled on ICD/Pacemaker device Receives: Device: Cardiac Resynchronization Therapy |
| CRT-Off | Sham comparator | Cardiac Resynchronization Therapy disabled on ICD/Pacemaker device Receives: Device: Cardiac Resynchronization Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular function
The primary cardiac performance endpoint is global longitudinal right ventricular (RV) function assessed by myocardial strain analysis using Speckle Tracking Echocardiography (STE).
Other traditional echocardiographic RV function indexes will also be evaluated.
Measured: 8 weeks
Secondary outcomes (1)
Functional capacity
Will be assessed by 6-Minute Walk Test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: IRB Approval withdrawn
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rakesh Gopinathannair, MD, MA, FHRS, Principal investigator, University of LouisvilleMartin A Espinosa Ginic, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169076
- Sponsor's protocol ID
- 14.0338
- Acronym
- CRT-LVAD
- Status last verified
- Jan 2017
- First submitted
- 18 Jun 2014
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy in Patients With Left Ventricular Assist Devices
- ClinicalTrials.gov ID
- NCT02169076
- Acronym / sponsor ID
- CRT-LVAD / 14.0338
- Conditions
- Heart Failure
- Keywords
- Ventricular Assist Device, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB Approval withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Jun 2014 (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.
Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy (CRT) aims to restore the synchronized contraction of the heart and has proven to be beneficial for improving ejection fraction of both right and left ventricle as well as quality of life in selected heart failure patients. The role of CRT in patients with LVADs is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function in LVAD patients and improve their quality-of-life.
The specific questions that this study aims to answer are:
- What are the effects of CRT on the function of the non-supported right ventricle in patients with an implanted LVAD?
- Can the effects of CRT on cardiac function positively impact quality-of-life and exercise capacity in LVAD recipients?
In this study patients with a previously implanted CRT device, who later receives an LVAD, will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients will be followed for an 8-week period, and then switched over to the opposite CRT status. The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart function will be assessed with comprehensive echocardiographic studies during the CRT "on" and CRT "off" periods. Quality-of-life and exercise capacity will be assessed with a standardized questionnaire and a 6-Minute Walk Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-On | Active comparator | Device: Cardiac Resynchronization TherapyCardiac Resynchronization Therapy enabled on ICD/Pacemaker device |
| CRT-Off | Sham comparator | Device: Cardiac Resynchronization TherapyCardiac Resynchronization Therapy disabled on ICD/Pacemaker device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart failure patients with previously implanted Bi-Ventricular pacemaker / defibrillator, and continuous flow LVAD (Heart Mate II® or HeartWare®)
- The LVAD must be implanted between 8 weeks and 18 months prior to enrollment
- Patients should be at least 3 weeks post discharge from the LVAD implant hospitalization
Key exclusion criteria (11 listed)
- Severe decompensated right ventricular failure defined as requiring any of the following:
- Severe aortic regurgitation documented by echocardiography or cardiac catheterization
- Stage IV or greater kidney disease (GFR < 30 mL/min/1.73 m2)
- Active infection (not including controlled chronic driveline infection on suppressive antibiotic therapy)
- Biventricular pacing < 90 % of time due to uncontrolled arrhythmias
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 |
|---|---|---|
| Cardiac Resynchronization TherapyThe cardiac resynchronization therapy of the ICD/Pacemaker device of the patients enrolled in the study will be programed under a standardized protocol and enabled or disabled in a crossover fashion during the study. | Device | CRT-Off, CRT-On |
Primary outcome
Right ventricular function
Time frame: 8 weeks
The primary cardiac performance endpoint is global longitudinal right ventricular (RV) function assessed by myocardial strain analysis using Speckle Tracking Echocardiography (STE). Other traditional echocardiographic RV function indexes will also be evaluated.
1 secondary outcome
Functional capacity
Time frame: 8 weeks
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 5 Jan 2017.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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.
Rakesh Gopinathannair, MD, MA, FHRS principal investigator
University of Louisville
Martin A Espinosa Ginic, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy in people with Heart Failure, run by University of Louisville 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 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: withdrawn, as of the sponsor's last update on 5 Jan 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 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. Some participants in this study may receive a placebo. 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?
Right ventricular function (time frame: 8 weeks). 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 5 Jan 2017.