Heart Failure Ventricular Pressure Time Profile

Heart Failure Clinical Trial

— HF-VFM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791074
• Other study ID #: 2013/365/C
• Status: Completed
• Phase: N/A
• First received: May 31, 2016
• Last updated: March 30, 2017
• Start date: May 2013
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: National Heart Centre Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Centre Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First occurrence of cardiovascular event		1 Year