Heart FailureddNCT01115764
LV Diastolic Dysfunction Among the Patients With Systolic Heart Failure-clinical Significance and Prognostic Importance.
An observational study of Heart Failure, run by Meir Medical Center.
Trial summary
Aims: To test the hypothesis that Diastolic dysfunction severity correlates with adverse clinical outcome in patients with systolic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jun 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: Study population This study will be performed on the base of Natania Heart Institute (out of hospital clinic). Within community-based population study we'll select the patients with LV systolic dysfunction. The participants will be classified according to their LV systolic function, functional class (NYHA) of HF. Approximately 200 subjects will be enrolled.
Summary of Subject Eligibility criteria:
- Men and women >18 years of age.
- HF of> 3 mo duration and NYHA class II, III, or IV at time of randomization.
- LVEF <45%
- Blood pressure <160/100
- No HF primarily due to valvular heart disease and no clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization.
- No implantable ICD or CRT within 30 days prior to randomization.
- No chemo- or radio-therapy for treatment of a malignancy within 6 months prior to randomization or clinical evidence of current malignancy with the following exception: local BCC of the skin or cervical intraepithelial neoplasia.
- Serum creatinine<2.5 mg/dl
Trial locations and contacts
No sites are listed yet.
About this study
Official title: LV Diastolic Dysfunction Among the Patients With Systolic Heart Failure
Aims: To test the hypothesis that Diastolic dysfunction severity correlates with adverse clinical outcome in patients with systolic heart failure.
Read the detailed description
Recent studies have explored the prognostic role of TDI-derived parameters in major cardiac diseases, such as heart failure, acute myocardial infarction, and hypertension.(1-3). In these conditions, myocardial mitral annular or basal segmental (Sm) systolic and early diastolic (Ea or Em) velocities have been shown to predict mortality or cardiovascular events. In particular, those with reduced Sm or Em values of <3 cm/s have a very poor prognosis. In heart failure and after myocardial infarction, noninvasive assessment of LV diastolic pressure by transmitral to mitral annular early diastolic velocity ratio (E/Ea or E/Em) is a strong prognosticator, especially when E/Ea is > or =15. (3) Conventional Doppler indices and TDI parameters correlated with functional class in patients with advanced heart failure. The E/E' ratio, which probably reflects high LV end-diastolic pressure, was the best measure for differentiating patients with functional class III and IV, and it also correlated with cardiac mortality and hospitalization for worsening heart failure, thereby providing additional value to standard echocardiographic measures(4-5) In our study we'll try to demonstrate that clinical deterioration of patients with LV systolic dysfunction directly correlates with parameters of their diastolic function and that these parameters more predictable than changes in LVEF.
This study will be performed on the base of Natania Heart Institute (out of hospital clinic).
Within community-based population study we'll select the patients with LV systolic dysfunction.
The participants will be classified according to their LV systolic function, functional class (NYHA) of HF.
Approximately 200 subjects will be enrolled.
The participants will be evaluate according their baseline features, clinical status using EQ-5D score, KCCQ Overall Summary Score, KCCQ Symptom Frequency Score.
After enrolment all our patients will undergo:
- Maximal work capacity testing (in METS) per BRUCE protocol,
- HR response estimation,
- 6-min walk test (to walk down 100 foot corridor to cover as much as possible in 6min)
- VO2 estimation using the knowing formula VO2 (mlO2/kg/min) = (mphX2.68)+(1.8X26.82XmphXgrade+100)+3.5 1MET =3.5 ml Q2/kg/min
- Echocardiography will be performed by VIVID -7 with 3.7 MHz probe All subjects examined with color TDI, FPV, two-dimensional and M-mode echo in the left lateral decubitus position.
Follow-up Follow-up at least 2 years With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year
- Conditions
- Heart Failure
- Keywords
- diastolic dysfunction
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
-Time to death from any cause or fist hospital admission for worsening HF, whichever occurs fist.
Follow-up -2 y With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year
Measured: 2 y
Secondary outcomes (1)
Change from baseline to month 6 : in KCCQ Overall Summary Score
Change from baseline to month 6 :
in KCCQ Overall Summary Score
in KCCQ Symptom Frequency Score.
of EQ-5D
in NYHA class of each time- point.
in maximal work capacity
in 6-min walk test
Change in VO2
Total number of hospital admission for worsening HF
Total duration of hospital admission for worsening HF
Total number of hospital admission for non-fatal c-v event, resuscitated sudden death, arrhythmia, new onset atrial fibrillation.
Measured: 6 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012 (estimated)
- Study completionJun 2012 (estimated)
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
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Korotinsky Svetlana, doctor, Principal investigator, Israel: Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115764
- Sponsor's protocol ID
- MMC10023/2010kCTIL
- Acronym
- dd
- Status last verified
- May 2010
- First submitted
- 2 May 2010
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LV Diastolic Dysfunction Among the Patients With Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT01115764
- Acronym / sponsor ID
- dd / MMC10023/2010kCTIL
- Conditions
- Heart Failure
- Keywords
- diastolic dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 4 May 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.
Aims: To test the hypothesis that Diastolic dysfunction severity correlates with adverse clinical outcome in patients with systolic heart failure.
Detailed description
Recent studies have explored the prognostic role of TDI-derived parameters in major cardiac diseases, such as heart failure, acute myocardial infarction, and hypertension.(1-3). In these conditions, myocardial mitral annular or basal segmental (Sm) systolic and early diastolic (Ea or Em) velocities have been shown to predict mortality or cardiovascular events. In particular, those with reduced Sm or Em values of <3 cm/s have a very poor prognosis. In heart failure and after myocardial infarction, noninvasive assessment of LV diastolic pressure by transmitral to mitral annular early diastolic velocity ratio (E/Ea or E/Em) is a strong prognosticator, especially when E/Ea is > or =15. (3) Conventional Doppler indices and TDI parameters correlated with functional class in patients with advanced heart failure. The E/E' ratio, which probably reflects high LV end-diastolic pressure, was the best measure for differentiating patients with functional class III and IV, and it also correlated with cardiac mortality and hospitalization for worsening heart failure, thereby providing additional value to standard echocardiographic measures(4-5) In our study we'll try to demonstrate that clinical deterioration of patients with LV systolic dysfunction directly correlates with parameters of their diastolic function and that these parameters more predictable than changes in LVEF.
This study will be performed on the base of Natania Heart Institute (out of hospital clinic).
Within community-based population study we'll select the patients with LV systolic dysfunction.
The participants will be classified according to their LV systolic function, functional class (NYHA) of HF.
Approximately 200 subjects will be enrolled.
The participants will be evaluate according their baseline features, clinical status using EQ-5D score, KCCQ Overall Summary Score, KCCQ Symptom Frequency Score.
After enrolment all our patients will undergo:
- Maximal work capacity testing (in METS) per BRUCE protocol,
- HR response estimation,
- 6-min walk test (to walk down 100 foot corridor to cover as much as possible in 6min)
- VO2 estimation using the knowing formula VO2 (mlO2/kg/min) = (mphX2.68)+(1.8X26.82XmphXgrade+100)+3.5 1MET =3.5 ml Q2/kg/min
- Echocardiography will be performed by VIVID -7 with 3.7 MHz probe All subjects examined with color TDI, FPV, two-dimensional and M-mode echo in the left lateral decubitus position.
Follow-up Follow-up at least 2 years With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population This study will be performed on the base of Natania Heart Institute (out of hospital clinic). Within community-based population study we'll select the patients with LV systolic dysfunction. The participants will be classified according to their LV systolic function, functional class (NYHA) of HF. Approximately 200 subjects will be enrolled.
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
-Time to death from any cause or fist hospital admission for worsening HF, whichever occurs fist.
Time frame: 2 y
Follow-up -2 y With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year
1 secondary outcome
Change from baseline to month 6 : in KCCQ Overall Summary Score
Time frame: 6 mo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2010.
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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.
Korotinsky Svetlana, doctor principal investigator
Israel: Clalit Health Services
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 4 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Korotinsky Svetlana, doctor (03-6313870, sv_korot@walla.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Time to death from any cause or fist hospital admission for worsening HF, whichever occurs fist. (time frame: 2 y). 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 4 May 2010.