Heart Failure With Reduced Ejection Fraction Clinical Trial
— CHILISALTOfficial 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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | August 31, 2018 |
Est. primary completion date | June 29, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: - Patients younger than 18 years. - Patients who not taking or taking <2 weeks Sacubitril Valsartan - Patients who had a CIED which not using OptiVol algoritm for impedance measurement. - Patients with structural pulmonary disease - Patients with obstructive sleep apnea syndrome who using a continuous positive airway pressure device - Patients with CIED pocket abcess |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Izmir |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in intrathoracic impedance values (ohms) between baseline and 14th and 28th days of Sacubutril/Valsartan treatment | Main outcome parameter is the change in intrathoracic impedance values (ohms) measuring with a CIED using its RV-coil to can vector between baseline (before Sacubutril/Valsartan treatment) and, 14th and 28th days of Sacubutril/Valsartan treatment. (Baseline value minus 14th day value) (Baseline Value minus 28 th day value) (Ohms) ( Decreasing in intrathoracic impedance has been shown to predict heart failure hospitalizations and all-cause mortality in patients with HFrEF. | Baseline (1st day), 14 th day and 28th day. (Screening=-10 to -1 day, Enrollment (Baseline Visit), Visit 1 (14+/-2 days), Visit 2 (28+/-4 days) | |
Primary | Change in OptiVol Index Values (ohm-days) between baseline and 14th and 28th days of Sacubutril/Valsartan treatment. | Change in Optivol Index values (ohm-days) measuring with a CIED using its RV-coil to can vector between baseline (before Sacubutril/Valsartan treatment) and, 14th and 28th days of Sacubutril/Valsartan treatment. (Baseline value minus 14th day value) (Baseline Value minus 28 th day value) (Ohm-days) Decreasing in intrathoracic impedance derived fluid indices such as OptiVol Fluid Index, has been shown to predict heart failure hospitalizations and all-cause mortality in patients with HFrEF. | Baseline, 14th and 28th days of Sacubitril/Valsartan treatment | |
Secondary | Change in body weight (kilogram) | Differences in Morning Body weight (kilogram) at fasting state between baseline and 14 th, 28 th days of Sacubitril/Valsartan treatment. | Baseline, 14 th day and 28 th day | |
Secondary | Change in cumulative diuretic dose (miligram per day) | Changing of personal, current cumulative diuretic dose ( Between baseline and 14 th, 28 th days of Sacubitril/Valsartan treatment) | Baseline, 14 th day, and 28 th day | |
Secondary | Requirement of intravenous diuretic therapy | Requirement of intravenous a loop diuretic due to congestive status (inpatient and/or outpatient) (Admission times) | Baseline, 14 th day, and 28 th day | |
Secondary | Change in the clinical summary score on the Kansas City Cardiomyopathy Questionnaire (KCCQ). | 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) | Baseline, 28 th day |
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