Heart Failure Clinical Trial
Official title:
Heart Failure HemOdynamic Prognostic Evaluation and OutcomE (HF-HOPE) Study
Summary of the HF-HOPE study:
Background and existing knowledge gap:
As per the Canadian Chronic Disease Surveillance System, about 1 in 12 Canadian adults aged
≥20 live with diagnosed heart disease. Every hour, about 12 Canadian adults aged ≥20 die due
to heart failure (HF). It is estimated that HF results in direct costs of more than $2.8
billion per year in Canada alone. As per the Canadian Society of Cardiology, heart failure is
defined as "a complex clinical syndrome in which abnormal heart function results in, or
increases the subsequent risk of, clinical symptoms and signs of reduced cardiac output
and/or pulmonary or systemic congestion at rest or with stress". Although HF is defined as
"reduced cardiac output state" no objective parameters are set to define the condition.
Invasive monitoring is routinely used in hemodynamic evaluation of critically ill patients
admitted in the hospital, however, there is no reliable tool available to measure hemodynamic
parameters that may predict, immediate or long-term, risk of worst health outcomes in stable
HF patients. We hypothesize that non-invasive bioimpedance-based hemodynamic parameters can
be used as a predictive tool for health outcomes in patients with HF. To ascertain this, we
propose the first of its kind HF-HOPE study.
Objectives of HF-HOPE study are to 1) characterize hemodynamic measures of resting versus
post-exercise (mounted ergometer) in patients with all-comer stable HF subjects, irrespective
of their HF etiology using Non-Invasive Cardiac System (NICaS); 2) correlate NICaS-derived
hemodynamic parameters to identify, early- and long-term risk of worse health outcomes
(unplanned hospital admission due to HF or arrhythmias; listing for heart
transplantation/palliative care; and death); 3) correlate the lean body mass (muscle and
skeleton) with their body mass index (kg/m2) and the risk of worse health outcomes; and 4)
Nested cohort study: identify the outcome-associated biomarkers of chronic HF by employing a
non-targeted metabolomics/lipidomics approach.
Methods: The HF-HOPE is a single center, prospective, double-blind, pragmatic clinical study.
It will be conducted at St. Boniface general hospital, Manitoba's tertiary cardiac center.
Patients aged ≥18 years, irrespective of any sex or gender, with confirmed diagnosis of HF
will be enrolled in the study. Hemodynamic measurements (stroke volume, cardiac output,
cardiac index, total peripheral vascular resistance, and cardiac power index) will be
assessed using NICaS at 3-times (at rest in supine, siting position as well as after exercise
on a mounted ergometer) at baseline and 6 months (±1 month) in each enrolled participant.
Patients will be followed to record health outcomes as outlined above, each year. The BodPod,
air displacement plathysmography device will be used to determine body compositions at
baseline and 6-month. Baseline demographic data will be gathered. To optimize the use of
clinical resources, we will collect blood and urine samples for non-selective metabolomics
and lipidomics profiling by adopting -omics approach as a nested cohort study. Statistical
analysis: Assuming the 8 to 12% 1-year mortality rate following admission with HF, a
projected sample size of 500 would be suffice. Conservatively 4 covariates will be included
in multivariable statistical models, while testing the independent effect of the relevant
NICaS parameters of interest. We will perform subgroup analysis using age, sex, ethnicity,
concomitant disease conditions, medications, and lean body mass.
Anticipated outcomes and future implications: The HF-HOPE study is the first of its kind
study employing non-invasive hemodynamic parameters to predict worsening health outcomes over
time in HF patients. The successful outcomes will provide a promising cost effective, rapid,
and reliable tool to predict worsening health outcomes before it actually lead to
hospitalization, tissue damage or death. This early warnings will provide adequate time for
appropriate intervention. The HF- HOPE study has been meticulously designed to replicate the
pragmatic conditions while assessing the non-invasive hemodynamic measurements to widen the
knowledge translation of outcomes to change the clinical practice of HF patient management.
Further, this may provide supporting data for future randomized trial to replace the costly,
resource-intense, and complex invasive tool to determine hemodynamic measurements in HF
patients.
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