Heart Failure Ventricular Pressure Time Profile (HF-VFM)

Singapore Health Services (SingHealth)

Status: Completed

Conditions: Heart Failure

Treatments: Other: Arterial tonometry; Other: NTproBNP; Other: Echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT02791074

2013/365/C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

75 participants in 2 patient groups

Control

Description:

Healthy Volunteers will undergo the following studying procedures: Echocardiography Arterial tonometry

Treatment:

Other: Arterial tonometry

Other: Echocardiography

Heart Failure Patients

Description:

Patients will undergo the following studying procedures: NTproBNP Echocardiography Arterial tonometry

Treatment:

Other: Arterial tonometry

Other: NTproBNP

Other: Echocardiography