Overview

This trial is active, not recruiting.

Condition heart failure
Treatments ntprobnp, echocardiography, arterial tonometry
Sponsor National Heart Centre Singapore
Start date May 2013
End date February 2017
Trial size 75 participants
Trial identifier NCT02791074, 2013/365/C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Healthy Volunteers will undergo the following studying procedures: Echocardiography Arterial tonometry
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.
arterial tonometry
A noninvasive method to obtain arterial pressure waveform.
Patients will undergo the following studying procedures: NTproBNP Echocardiography Arterial tonometry
ntprobnp
To assess its level in the blood, as a marker of heart failure presence and severity.
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.
arterial tonometry
A noninvasive method to obtain arterial pressure waveform.

Primary Outcomes

Measure
First occurrence of cardiovascular event
time frame: 1 Year

Eligibility Criteria

Male or female participants from 21 years up to 90 years old.

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.

Additional Information

Official title Non-invasive Determination of Intra-left Ventricular Pressure-time Profile for Diagnosis of Heart Failure With Normal and Reduced Ejection Fraction.
Principal investigator Thu Thao Le, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by National Heart Centre Singapore.