Heart FailureHF-VFMNCT02791074
Heart Failure Ventricular Pressure Time Profile
An observational study of Heart Failure, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
This proposed study aim to: 1. Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers. 2. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- NTproBNP, Echocardiography and Arterial tonometry
- How many people
- 75 participants
- Where
- 1 siteSingapore
- Study dates
- May 2013to Mar 2017
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 35 diagnosed heart failure patient will be recruited from primary care clinic, outpatient clinics and hospital ward from NHCS. 40 Healthy Volunteer control group.
Who may be able to join
- Either
- has presented to hospital with a primary diagnosis of Heart Failure or
- is attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either:
- resulted in a hospital admission (primary diagnosis) or
- was treated in out-patient clinic
- LVEF >50% is used as cut-off value for HFNEF and LVEF < 50% for HFREF.
- NT-proBNP within 7 days of admission > 220pg/ml. If there is no result available, NT-proBNP on the same day as echo scan must be > 220pg/ml.
Who cannot join
- Haemodynamically significant valve disease defined as more than mild degree of valve stenosis, or more than moderate degrees of mitral or aortic valve regurgitation.
- History of valvular disease, i.e. rheumatic heart disease and/or having undergone valvular replacement.
- Isolated right heart failure due to pulmonary disease.
- Presence of haemodynamically significant obstructive lesions of left ventricular outflow tract.
- History of any organ transplant or who was on a transplant list (life expectancy < 6 months at time of enrollment).
- Presence of end-stage renal failure.
- Pregnancy.
- The patient is unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National Heart Centre Singapore
Singapore, Singapore, 169609
About this study
Official title: Non-invasive Determination of Intra-left Ventricular Pressure-time Profile for Diagnosis of Heart Failure With Normal and Reduced Ejection Fraction.
This proposed study aim to:
- Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers.
- Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
Read the detailed description
Heart failure (HF) is a common disease and its syndrome is difficult to diagnose. HF with reduced ejection fraction (HFREF) may be diagnosed based on impaired LVEF (<50%). However, diagnosis of HF with normal ejection fraction (HFNEF) is mainly based on the presence of signs and symptoms.
Central to diagnosis of HF is estimation of intra-cardiac pressure, which can only be obtained from invasive catheterization.
This proposed study aim to:
- Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers.
- Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
- Conditions
- Heart Failure
- Being tested
- NTproBNP, Echocardiography, Arterial tonometry
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTproBNPOther
To assess its level in the blood, as a marker of heart failure presence and severity.
EchocardiographyOther
To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help us understand the type and severity of heart failure.
Arterial tonometryOther
A noninvasive method to obtain arterial pressure waveform.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy Volunteers will undergo the following studying procedures:
Echocardiography Arterial tonometry Receives: Other: Echocardiography; Other: Arterial tonometry | |
| Heart Failure Patients | Patients will undergo the following studying procedures:
NTproBNP Echocardiography Arterial tonometry Receives: Other: NTproBNP; Other: Echocardiography; Other: Arterial tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of cardiovascular event
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMay 2013
- Primary completionFeb 2017
- Study completionMar 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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thu Thao Le, PHD, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791074
- Sponsor's protocol ID
- 2013/365/C
- Acronym
- HF-VFM
- Status last verified
- Mar 2017
- First submitted
- 31 May 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Determination of Intra-left Ventricular Pressure-time Profile for Diagnosis of Heart Failure With Normal and Reduced Ejection Fraction.
- ClinicalTrials.gov ID
- NCT02791074
- Acronym / sponsor ID
- HF-VFM / 2013/365/C
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Jun 2016 (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.
This proposed study aim to:
- Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers.
- Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
Detailed description
Heart failure (HF) is a common disease and its syndrome is difficult to diagnose. HF with reduced ejection fraction (HFREF) may be diagnosed based on impaired LVEF (<50%). However, diagnosis of HF with normal ejection fraction (HFNEF) is mainly based on the presence of signs and symptoms.
Central to diagnosis of HF is estimation of intra-cardiac pressure, which can only be obtained from invasive catheterization.
This proposed study aim to:
- Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers.
- Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Echocardiography, Other: Arterial tonometryHealthy Volunteers will undergo the following studying procedures: Echocardiography Arterial tonometry |
| Heart Failure Patients | – | Other: NTproBNP, Other: Echocardiography, Other: Arterial tonometryPatients will undergo the following studying procedures: NTproBNP Echocardiography Arterial tonometry |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 35 diagnosed heart failure patient will be recruited from primary care clinic, outpatient clinics and hospital ward from NHCS. 40 Healthy Volunteer control group.
Key inclusion criteria (7 listed)
- Either
- LVEF >50% is used as cut-off value for HFNEF and LVEF < 50% for HFREF.
- NT-proBNP within 7 days of admission > 220pg/ml. If there is no result available, NT-proBNP on the same day as echo scan must be > 220pg/ml.
Key exclusion criteria (8 listed)
- Haemodynamically significant valve disease defined as more than mild degree of valve stenosis, or more than moderate degrees of mitral or aortic valve regurgitation.
- History of valvular disease, i.e. rheumatic heart disease and/or having undergone valvular replacement.
- Isolated right heart failure due to pulmonary disease.
- Presence of haemodynamically significant obstructive lesions of left ventricular outflow tract.
- History of any organ transplant or who was on a transplant list (life expectancy < 6 months at time of enrollment).
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 |
|---|---|---|
| NTproBNPTo assess its level in the blood, as a marker of heart failure presence and severity. | Other | Heart Failure Patients |
| EchocardiographyTo measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help us understand the type and severity of heart failure. | Other | Control, Heart Failure Patients |
| Arterial tonometryA noninvasive method to obtain arterial pressure waveform. | Other | Control, Heart Failure Patients |
Primary outcome
First occurrence of cardiovascular event
Time frame: 1 Year
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 31 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Thu Thao Le, PHD principal investigator
National Heart Centre Singapore
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 National Heart Centre Singapore at 1 site in Singapore.
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 7 inclusion and 8 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 31 Mar 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 Singapore. 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?
First occurrence of cardiovascular event (time frame: 1 Year). 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 31 Mar 2017.