Heart Failure With Reduced Ejection Fraction Clinical Trial
Official title:
Changes in Intrathoracic Impedance During Sacubitril/Valsartan Treatment: CHILISALT Study
The CHILISALT Study aimed to explore the effect of angiotensin-neprilysin inhibition on intrathoracic impedance and -derived fluid index in HFrEF patients who had a device for cardiac resynchronization therapy and/or an implantable cardioverter-defibrillator (ICD; Medtronic Inc., Minneapolis, MN) allowing continuous measurement of intrathoracic impedance.
Background Cardiac implantable electronic devices (CIEDs) that are improving clinical
outcomes in selected heart failure with reduced ejection fraction (HFrEF) patients also
collect valuable diagnostic information from continuous monitoring of several physiological
variables such as intrathoracic electrical impedance. Intrathoracic electrical impedance
monitoring has been used as a tool to evaluate pulmonary congestion. Intrathoracic impedance
is inversely correlated to pulmonary volume expansion and has been linked to cardiac filling
pressures. Decreasing in intrathoracic impedance and -derived fluid indices such as OptiVol
Fluid Index, has been shown to predict heart failure hospitalizations and all-cause mortality
in patients with HFrEF. Furthermore, studies also have shown the usefulness of monitoring
impedance to initiate timely interventions preventing decompensation.
In patients with symptomatic HFrEF, the PARADIGM-HF trial demonstrated that
sacubitril/valsartan significantly reduced the primary endpoint of cardiovascular mortality
and heart failure hospitalization, compared with enalapril. The rate of all-cause mortality
was also significantly reduced. Subsequently, Sacubitril/Valsartan is recommended by current
guidelines as foundational therapy for many patients with symptomatic HFrEF.
However as a natriuretic agent, effects of Sacubitril/Valsartan treatment on intrathoracic
impedance and fluid index remains unclear.
Objective The CHILISALT Study aimed to explore the effect of angiotensin-neprilysin
inhibition on intrathoracic impedance and fluid index values in HFrEF patients who were
implanted with a device for cardiac resynchronization therapy and/or an implantable
cardioverter-defibrillator (ICD; Medtronic Inc., Minneapolis, MN) allowing continuous
measurement of intrathoracic impedance and OptiVol Fluid Index. Main outcome parameters are
the change in intrathoracic impedanceand OptiVol Index values between baseline (before
Sacubutril/Valsartan treatment) and, 14th and 28th days of Sacubutril/Valsartan treatment.
Material and Methods CHILISALT Study will designed as national, multicentre,
non-interventional, observational, single arm cohort study. Study population will identified
from dedicated CIED Clinics from participating centres. Patients will eligible if they had
already taking Sacubitril/Valsartan for ≥2 weeks and had been implanted with CIED for ≥3
months. Additionally, eligible patients must have a CIED before Sacubitril/Valsartan
prescription date. Due to descriptive (proof of mechanism) design of the CHILISALT Study a
formal population volume calculation will not be made. However, after minimum 24 patients
included an interim analysis will be done in terms of changes in impedance values and other
related parameters between baseline and after Sacubitril/Valsartan treatment. An independent
data monitoring committee will decide to enrol or to finalize the study according to main
outcome variable distribution. Main outcome parameters are the change in intrathoracic
impedance and OptiVol Fluid index values between baseline (before Sacubutril/Valsartan
treatment) and, 14th and 28th days of Sacubutril/Valsartan treatment. As a tool to evaluate
pulmonary fluid status, intrathoracic impedance measuring quantifies impedance changes. CIEDs
measured intrathoracic impedance (ohms) using the RV-coil to can vector. Impedance-derived
fluid index will obtained using a cumulative sum mathematical model that calculates the
differences between impedance measured in ohms (measured impedance) and a reference
impedance. OptiVol Fluid index will be expressed in ohm-days. It was demonstrated that the
index value exceeded 60 ohm-days, the crossing of this threshold value predicted both
increased morbidity and mortality. Other possible confounders such as change in body weight
(kilogram), current diuretic dose (miligram per day), requirement of intravenous diuretic
therapy (yes/no), and the change from baseline to 28th day of the treatment in the clinical
summary score on the Kansas City Cardiomyopathy Questionnaire (KCCQ; on a scale from 0 to
100, with higher scores indicating fewer symptoms and physical limitations associated with
heart failure) is selected as secondary outcomes.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Completed |
NCT03614169 -
Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB
|
N/A | |
Recruiting |
NCT05278962 -
HF Patients With LVADs Being Treated With SGLT2i
|
Phase 4 | |
Completed |
NCT04210375 -
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
|
Phase 1 | |
Completed |
NCT05001165 -
Dashboard Activated Services and Tele-Health for Heart Failure
|
N/A | |
Active, not recruiting |
NCT03701880 -
Early Use of Ivabradine in Heart Failure
|
N/A | |
Recruiting |
NCT05650658 -
Left vs Left Randomized Clinical Trial
|
N/A | |
Recruiting |
NCT05992116 -
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
|
||
Recruiting |
NCT05365568 -
Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study
|
N/A | |
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
|
||
Not yet recruiting |
NCT04420065 -
Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure
|
N/A | |
Terminated |
NCT03479424 -
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
|
||
Completed |
NCT02113033 -
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
|
Phase 2 | |
Recruiting |
NCT03209180 -
Immediate Release Versus Slow Release Carvedilol in Heart Failure
|
Phase 4 | |
Recruiting |
NCT05299879 -
Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
|
||
Recruiting |
NCT05637853 -
Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
|
||
Completed |
NCT03870074 -
CPET Predicts Long-term Survival and Positive Response to CRT
|
||
Recruiting |
NCT04590001 -
Effect of the MobiusHD® in Patients With Heart Failure
|
N/A | |
Recruiting |
NCT05072054 -
Comparison of Effects of Atorvastatin Versus Rosuvastatin on Cardiac Function in Heart Failure Patients
|
Phase 4 | |
Completed |
NCT06233695 -
Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
|