Changes in Intrathoracic Impedance During Sacubitril/Valsartan Treatment

NCT03359967 | Unknown DMC

• 1 other identifier: CH1HF
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Change in body weight (kilogram)

  Baseline, 14 th day and 28 th day

• Change in cumulative diuretic dose (miligram per day)

  Baseline, 14 th day, and 28 th day

• Requirement of intravenous diuretic therapy

  Baseline, 14 th day, and 28 th day

• Change in the clinical summary score on the Kansas City Cardiomyopathy Questionnaire (KCCQ).

  Baseline, 28 th day

Interventions

Entresto tablet DRUG

Changes in intrathoracic impedance and other related parameters between before- and after Sacubitril/Valsartan treatment collected via previously implanted device algoritm. (OptiVol Fluid Index)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Heart Failure with Reduced Ejection Fraction and had a CIED using OptiVol Fluid Index for intrathoracic impedance measurement.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Izmir: lead

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Central Study Contacts

Ugur O Turk, Assoc. Prof. FESC, ECDS

CONTACT

+905067021021; droturk@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD. Cardiologist, FESC, EHRA Cardiac Device Specialist

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: February 12, 2018
• Primary Completion: June 29, 2018
• Study Completion: August 31, 2018
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share