Heart Failure Ventricular Pressure Time Profile

NCT ID: NCT02791074

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Healthy Volunteers will undergo the following studying procedures:

Echocardiography Arterial tonometry

Echocardiography

Intervention Type 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

Intervention Type OTHER

A noninvasive method to obtain arterial pressure waveform.

Heart Failure Patients

Patients will undergo the following studying procedures:

NTproBNP Echocardiography Arterial tonometry

NTproBNP

Intervention Type OTHER

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

Echocardiography

Intervention Type 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

Intervention Type OTHER

A noninvasive method to obtain arterial pressure waveform.

Interventions

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NTproBNP

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

Intervention Type OTHER

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.

Intervention Type OTHER

Arterial tonometry

A noninvasive method to obtain arterial pressure waveform.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thu Thao Le, PHD

Role: PRINCIPAL_INVESTIGATOR

National Heart Centre Singapore

Locations

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National Heart Centre Singapore

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Other Identifiers

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2013/365/C

Identifier Type: -

Identifier Source: org_study_id