Heart Failure Ventricular Pressure Time Profile

NCT02791074 | Completed

• 1 other identifier: 2013/365/C
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This proposed study aim to:

1. 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. 2.Correlate calculated intra-LV pressure parameters with NT ProBNP levels.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• First occurrence of cardiovascular event

  1 Year

Study Arms (2)

Control

Healthy Volunteers will undergo the following studying procedures: Echocardiography Arterial tonometry

Other: Echocardiography; Other: Arterial tonometry

Heart Failure Patients

Patients will undergo the following studying procedures: NTproBNP Echocardiography Arterial tonometry

Other: NTproBNP; Other: Echocardiography; Other: Arterial tonometry

Interventions

NTproBNP OTHER

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

Heart Failure Patients

Echocardiography 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.

Control; Heart Failure Patients

Arterial tonometry OTHER

A noninvasive method to obtain arterial pressure waveform.

Control; Heart Failure Patients

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

35 diagnosed heart failure patient will be recruited from primary care clinic, outpatient clinics and hospital ward from NHCS. 40 Healthy Volunteer control group.

You may qualify if:

• Either
• has presented to hospital with a primary diagnosis of Heart Failure or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Heart Failure

Interventions

pro-brain natriuretic peptide (1-76)

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Thu Thao Le, PHD

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 6, 2016
• Study Start: May 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)