Clinical trial NCT02791074: Heart Failure Ventricular Pressure Time Profile
Official title: Non-invasive Determination of Intra-left Ventricular Pressure-time Profile for Diagnosis of Heart Failure With Normal and Reduced Ejection Fraction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First occurrence of cardiovascular event
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: National Heart Centre Singapore
name: Thu Thao Le, PHD
role: PRINCIPAL_INVESTIGATOR
References: