Heart Failure Ventricular Pressure Time Profile

Completed

• Conditions: Heart Failure
• Interventions: Other: Echocardiography; Other: NTproBNP; Other: Arterial tonometry

• Registration Number: NCT02791074
• Lead Sponsor: National Heart Centre Singapore

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-06
• Primary Completion: 2017-02
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Arterial tonometry	Healthy Volunteers will undergo the following studying procedures: Echocardiography Arterial tonometry
Heart Failure Patients	Arterial tonometry	Patients will undergo the following studying procedures: NTproBNP Echocardiography Arterial tonometry
Control	Echocardiography	Healthy Volunteers will undergo the following studying procedures: Echocardiography Arterial tonometry
Heart Failure Patients	NTproBNP	Patients will undergo the following studying procedures: NTproBNP Echocardiography Arterial tonometry
Heart Failure Patients	Echocardiography	Patients will undergo the following studying procedures: NTproBNP Echocardiography Arterial tonometry

Primary Outcome Measures

Name	Time	Method
First occurrence of cardiovascular event	1 Year

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore