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Completed

NCT Number: NCT02791074

Heart Failure Ventricular Pressure Time Profile

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Heart Centre Singapore

Singapore, 169609

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

NTproBNP

Other

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

echocardiography

Other

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 tonometry

Other

A noninvasive method to obtain arterial pressure waveform.

Primary outcomes

  1. First occurrence of cardiovascular event

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

National Heart Centre Singapore

Other

Registry information

Official study title

Non-invasive Determination of Intra-left Ventricular Pressure-time Profile for Diagnosis of Heart Failure With Normal and Reduced Ejection Fraction.

Acronym: HF-VFM

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2016
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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