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Heart Failure Ventricular Pressure Time Profile

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02791074
Acronym
HF-VFM
Enrollment
75
Registered
2016-06-06
Start date
2013-05-31
Completion date
2017-03-31
Last updated
2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

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.

Interventions

OTHERNTproBNP

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

OTHEREchocardiography

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.

A noninvasive method to obtain arterial pressure waveform.

Sponsors

National Heart Centre Singapore
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
First occurrence of cardiovascular event1 Year

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026