Heart Failure Ventricular Pressure Time Profile (HF-VFM)

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:

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Echocardiography; Other: Arterial tonometry; Other: NTproBNP

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 Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
First occurrence of cardiovascular event	1 Year

Collaborators and Investigators

• Sponsor: National Heart Centre Singapore
• Investigators: Principal Investigator: Thu Thao Le, PHD, National Heart Centre Singapore

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: May 31, 2016
• First Posted (Estimate): June 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2013/365/C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No