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Heart Failure Ventricular Pressure Time Profile (HF-VFM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791074
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
National Heart Centre Singapore

Study Description
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Brief 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. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.

Condition or disease Intervention/treatment
Heart Failure Other: NTproBNP Other: Echocardiography Other: Arterial tonometry

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:

  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. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
Study Design
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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Non-invasive Determination of Intra-left Ventricular Pressure-time Profile for Diagnosis of Heart Failure With Normal and Reduced Ejection Fraction.
Study Start Date : May 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
Control

Healthy Volunteers will undergo the following studying procedures:

Echocardiography Arterial tonometry

 Other: Echocardiography
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.

Other: Arterial tonometry
A noninvasive method to obtain arterial pressure waveform.
Heart Failure Patients

Patients will undergo the following studying procedures:

NTproBNP Echocardiography Arterial tonometry

 Other: NTproBNP
To assess its level in the blood, as a marker of heart failure presence and severity.

Other: Echocardiography
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.

Other: Arterial tonometry
A noninvasive method to obtain arterial pressure waveform.


Outcome Measures
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Primary Outcome Measures :
  1. First occurrence of cardiovascular event [ Time Frame: 1 Year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Either

    1. has presented to hospital with a primary diagnosis of Heart Failure or

    2. 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791074


Locations
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Singapore
National Heart Centre Singapore
Singapore, Singapore, 169609
Sponsors and Collaborators
National Heart Centre Singapore
Investigators
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Principal Investigator: Thu Thao Le, PHD National Heart Centre Singapore
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT02791074    
Other Study ID Numbers: 2013/365/C
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases