Heart FailureNCT00953953
Study of Left Ventricular Dyssynchrony in Heart Failure Patients
An observational study of Heart Failure, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Heart failure has become one of the major epidemics of the modern era. Despite optimal standard drug therapy, the prognosis of patients with heart failure remains poor. Patient with Heart Failure are prone to have "dyssynchrony" which means that there are electrical disturbances that cause the heart to pump blood in… 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?
- Phillips ultrasound system
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Oct 2011
- 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: Acutely Decompensated Systolic HF group: patients who are admitted to Albert Einstein Medical Center on the HF service. Chronic HF on Dialysis group: patients at the dialysis center at Albert Einstein Medical Center. Ambulatory Chronic HF group: patients who present to the Albert Einstein Medical Center HF clinic. Acutely Decompensated Diastolic HF group: patients who are admitted to Albert Einstein Medical Center on the HF service.
Who may be able to join
- Patients over the age of 18 and able to consent
- NYHA Class III or IV
- EF≤ 35%
- Diagnosis of acute congestive heart failure exacerbation by history or physical examination
- Ability to understand and willing to sign informed consent
- Willingness to follow-up for clinic visits at 30 days and 6 months
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- Patients over the age of 18 and able to consent
- NYHA Class II, III, or IV
- EF ≤ 35% with a screening echocardiogram
- Ability to understand and willing to sign informed consent
- Willingness to follow up at 30 days and 6 months via phone contact
- Patients over the age of 18 and able to consent
- NYHA Class II and III with an EF ≤ 35%
- Diagnosis of chronic heart failure and currently on optimal medical therapy, including ACE, or ARB, beta-blockers and diuretics including spironolactone
- Ability to understand and willing to sign informed consent
- Willingness to follow up as an outpatient at 30 days and 6 months
- Patients over the age of 18 and able to consent
- NYHA Class III or IV
- EF ≥ 45%
- Diagnosis of acute congestive heart failure exacerbation by history or physical examination
- Ability to understand and willing to sign informed consent
- Willingness to follow-up for clinic visits at 30 days and 6 months
Who cannot join
- Pacemaker
- Patients requiring and willing to sign informed consent
- Unwillingness to provide consent
- CHRONIC HEART FAILURE on DIALYSIS GROUP
- Unwillingness to provide consent
- Pacemaker
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- AMBULATORY CHRONIC HEART FAILURE GROUP
- Incapable of taking the 6-minute walk test due to any condition unrelated to heart failure
- Patients requiring chronic inotrope therapy
- Pacemaker
- Symptoms of angina limiting exercise ability
- Unwillingness to provide consent
- ACUTELY DECOMPENSATED DIASTOLIC HEART FAILURE GROUP
- Pacemaker
- Patients requiring inotrope support on admission
- Unwillingness to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Study of the Phenomenon of Dynamic Left Ventricular Dyssynchrony in Heart Failure Patients and Its Clinical Significance.
Heart failure has become one of the major epidemics of the modern era. Despite optimal standard drug therapy, the prognosis of patients with heart failure remains poor. Patient with Heart Failure are prone to have "dyssynchrony" which means that there are electrical disturbances that cause the heart to pump blood in an inefficient way. Ventricular dyssynchrony has been associated with increased mortality in patients with heart failure. Based on these observations, techniques have been developed to correct dyssynchrony. The investigators propose to investigate the change of dyssynchrony in relation to intravascular volume status and exercise in heart failure patients. The investigators also propose to examine dyssynchrony in the setting of acutely decompensated heart failure. The change in dyssynchrony will be followed to examine if it translates into clinical significance.
Read the detailed description
Heart failure has become one of the major epidemics of the modern era. Despite optimal standard drug therapy, the prognosis of patients with heart failure remains poor. It has been noted that 15% of all HF patients and 30% of those with NYHA class III and IV HF have intraventricular conduction delay, with a QRS duration >120 ms, most commonly manifested as LBBB. These electrical disturbances result in LV dyssynchrony, seen as a paradoxical septal wall motion activity, suboptimal ventricular filling and mitral regurgitation; thus further compromising an already dysfunctioning left ventricle. Ventricular dyssynchrony has been associated with increased mortality in patients with heart failure.
Based on these observations, techniques have been developed to correct dyssynchrony. Cardiac resynchronization therapy (CRT) has been shown to improve subjective and objective parameters in heart failure patients with QRS duration > 120msec. However, there is a group of heart failure patients who did not respond to CRT. Also it has been noted that approximately 30% of heart failure patients with QRS duration > 120 msec do not have actual mechanical dyssynchrony by tissue doppler imaging. The electromechanical discrepancy of ventricular dyssynchrony has been suggested as the possible explanation for the lack of response. Also, there are heart failure patients with normal QRS duration who do have mechanical dyssynchrony. These findings bring more emphasis to the importance of mechanical dyssynchrony than electrical dyssynchrony, which is measured by QRS duration on surface EKG.
There are many different modalities to quantify mechanical dyssynchrony. The most commonly used method is tissue doppler imaging (TDI). TDI measures the velocities of myocardial tissue and time to maximal velocities. Then, these are used to describe contractions of different wall segments. Strain and strain rates are more sophisticated ways to measure active segment contraction rather than passive movements.
We propose to investigate the change of dyssynchrony in relation to intravascular volume status and exercise in heart failure patients. We also propose to examine dyssynchrony in the setting of acutely decompensated heart failure. The change in dyssynchrony will be followed to examine if it translates into clinical significance.
- Conditions
- Heart Failure
- Being tested
- Phillips ultrasound system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phillips ultrasound systemDevice
The tissue doppler imaging color images will be acquired from two, three, and four-chamber apical views to assess the longitudinal contraction of the left ventricle.
| Study group | Role | What they receive |
|---|---|---|
| Acutely Decompensated Systolic HF | Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV). Receives: Device: Phillips ultrasound system | |
| Chronic HF Patients on Dialysis | Patients who have heart failure (defined as NYHA class II, III, or IV) and are on dialysis. Receives: Device: Phillips ultrasound system | |
| Ambulary Chronic HF | Patients with diagnosis of chronic heart failure (NYHA class II and III) who are on optimal medical therapy. Receives: Device: Phillips ultrasound system | |
| Acutely Decompensated Diastolic HF | Patients with moderate or severe Heart Failure (defined ast NYHA class III or IV). Receives: Device: Phillips ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acutely Decompensated Systolic HF Group:Assess the incidence of change in dyssynchrony at admission and prior to discharge during acute decompensated heart failure exacerbation hospitalization
Measured: 6 months
Chronic Heart Failure on Dialysis Group: Assess the incidence of change in dyssynchrony before, during, and after dialysis
Measured: 6 months
Ambulatory Chronic Heart Failure Patients Group: Assess the incidence of change in dyssynchrony at rest and during peak exercise in Chronic Heart failure patients.
Measured: 6 months
Acutely Decompensated Diastolic Heart Failure Group: Assess the incidence of change in dyssynchrony at admission and prior to discharge during acutely decompensated diastolic heart failure exacerbation hospitalization
Measured: 6 months
Secondary outcomes (1)
All four arms: Determine the change of dyssynchrony
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 posted6 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionOct 2011
- Study completionOct 2011
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darshak Karia, MD, Albert Einstein Healthcare Network
- Investigators
- Darshak Karia, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953953
- Sponsor's protocol ID
- HN 3052
- Status last verified
- Jan 2012
- First submitted
- 5 Aug 2009
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Phenomenon of Dynamic Left Ventricular Dyssynchrony in Heart Failure Patients and Its Clinical Significance.
- ClinicalTrials.gov ID
- NCT00953953
- Acronym / sponsor ID
- HN 3052
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Aug 2009 (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.
Heart failure has become one of the major epidemics of the modern era. Despite optimal standard drug therapy, the prognosis of patients with heart failure remains poor. Patient with Heart Failure are prone to have "dyssynchrony" which means that there are electrical disturbances that cause the heart to pump blood in an inefficient way. Ventricular dyssynchrony has been associated with increased mortality in patients with heart failure. Based on these observations, techniques have been developed to correct dyssynchrony. The investigators propose to investigate the change of dyssynchrony in relation to intravascular volume status and exercise in heart failure patients. The investigators also propose to examine dyssynchrony in the setting of acutely decompensated heart failure. The change in dyssynchrony will be followed to examine if it translates into clinical significance.
Detailed description
Heart failure has become one of the major epidemics of the modern era. Despite optimal standard drug therapy, the prognosis of patients with heart failure remains poor. It has been noted that 15% of all HF patients and 30% of those with NYHA class III and IV HF have intraventricular conduction delay, with a QRS duration >120 ms, most commonly manifested as LBBB. These electrical disturbances result in LV dyssynchrony, seen as a paradoxical septal wall motion activity, suboptimal ventricular filling and mitral regurgitation; thus further compromising an already dysfunctioning left ventricle. Ventricular dyssynchrony has been associated with increased mortality in patients with heart failure.
Based on these observations, techniques have been developed to correct dyssynchrony. Cardiac resynchronization therapy (CRT) has been shown to improve subjective and objective parameters in heart failure patients with QRS duration > 120msec. However, there is a group of heart failure patients who did not respond to CRT. Also it has been noted that approximately 30% of heart failure patients with QRS duration > 120 msec do not have actual mechanical dyssynchrony by tissue doppler imaging. The electromechanical discrepancy of ventricular dyssynchrony has been suggested as the possible explanation for the lack of response. Also, there are heart failure patients with normal QRS duration who do have mechanical dyssynchrony. These findings bring more emphasis to the importance of mechanical dyssynchrony than electrical dyssynchrony, which is measured by QRS duration on surface EKG.
There are many different modalities to quantify mechanical dyssynchrony. The most commonly used method is tissue doppler imaging (TDI). TDI measures the velocities of myocardial tissue and time to maximal velocities. Then, these are used to describe contractions of different wall segments. Strain and strain rates are more sophisticated ways to measure active segment contraction rather than passive movements.
We propose to investigate the change of dyssynchrony in relation to intravascular volume status and exercise in heart failure patients. We also propose to examine dyssynchrony in the setting of acutely decompensated heart failure. The change in dyssynchrony will be followed to examine if it translates into clinical significance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acutely Decompensated Systolic HF | – | Device: Phillips ultrasound systemPatients with moderate or severe Heart Failure (defined ast NYHA class III or IV). |
| Chronic HF Patients on Dialysis | – | Device: Phillips ultrasound systemPatients who have heart failure (defined as NYHA class II, III, or IV) and are on dialysis. |
| Ambulary Chronic HF | – | Device: Phillips ultrasound systemPatients with diagnosis of chronic heart failure (NYHA class II and III) who are on optimal medical therapy. |
| Acutely Decompensated Diastolic HF | – | Device: Phillips ultrasound systemPatients with moderate or severe Heart Failure (defined ast NYHA class III or IV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acutely Decompensated Systolic HF group: patients who are admitted to Albert Einstein Medical Center on the HF service. Chronic HF on Dialysis group: patients at the dialysis center at Albert Einstein Medical Center. Ambulatory Chronic HF group: patients who present to the Albert Einstein Medical Center HF clinic. Acutely Decompensated Diastolic HF group: patients who are admitted to Albert Einstein Medical Center on the HF service.
Key inclusion criteria (22 listed)
- Patients over the age of 18 and able to consent
- NYHA Class III or IV
- EF≤ 35%
- Diagnosis of acute congestive heart failure exacerbation by history or physical examination
- Ability to understand and willing to sign informed consent
Key exclusion criteria (16 listed)
- Pacemaker
- Patients requiring and willing to sign informed consent
- Unwillingness to provide consent
- CHRONIC HEART FAILURE on DIALYSIS GROUP
- Unwillingness to provide consent
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 |
|---|---|---|
| Phillips ultrasound systemThe tissue doppler imaging color images will be acquired from two, three, and four-chamber apical views to assess the longitudinal contraction of the left ventricle. | Device | Acutely Decompensated Diastolic HF, Acutely Decompensated Systolic HF, Ambulary Chronic HF, Chronic HF Patients on Dialysis |
Primary outcome
Acutely Decompensated Systolic HF Group:Assess the incidence of change in dyssynchrony at admission and prior to discharge during acute decompensated heart failure exacerbation hospitalization
Time frame: 6 months
Chronic Heart Failure on Dialysis Group: Assess the incidence of change in dyssynchrony before, during, and after dialysis
Time frame: 6 months
Ambulatory Chronic Heart Failure Patients Group: Assess the incidence of change in dyssynchrony at rest and during peak exercise in Chronic Heart failure patients.
Time frame: 6 months
Acutely Decompensated Diastolic Heart Failure Group: Assess the incidence of change in dyssynchrony at admission and prior to discharge during acutely decompensated diastolic heart failure exacerbation hospitalization
Time frame: 6 months
1 secondary outcome
All four arms: Determine the change of dyssynchrony
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 26 Jan 2012.
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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.
Darshak Karia, MD principal investigator
Albert Einstein Healthcare Network
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, run by Albert Einstein Healthcare Network 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 22 inclusion and 16 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 26 Jan 2012. 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?
Acutely Decompensated Systolic HF Group:Assess the incidence of change in dyssynchrony at admission and prior to discharge during acute decompensated heart failure exacerbation hospitalization (time frame: 6 months). The study lists 4 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 26 Jan 2012.