Effectiveness of Lung Impedance Guided Preemptive Therapy of Chronic Heart Failure Patients With Preserved Ejection Fraction (LVEF ≥ 45%) in Our Hospital's Outpatient Clinic
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
LI-Guided Therapy
Heart Failure Guidelines
Sponsored by

About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients hospitalized within past 12 months for heart failure
Exclusion Criteria:
- Dialysis patients
- Patients with GFR <25
- Patients with serious illness and life expectancy <12
- Mentally incompetent
Sites / Locations
- Hillel Yaffe Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LI-Guided Therapy
Control
Arm Description
One hundred and fifty chronic heart failure patients treated based on guidelines and LI-Guided Therapy.
One hundred and fifty chronic heart failure patients treated based on guidelines only.
Outcomes
Primary Outcome Measures
Reduced all cause, cardiovascular, and heart failure hospitalizations
Reduced mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT02661841
First Posted
January 20, 2016
Last Updated
June 17, 2020
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02661841
Brief Title
Effectiveness of Lung Impedance Guided Preemptive Therapy of Chronic Heart Failure Patients With Preserved Ejection Fraction (LVEF ≥ 45%) in Our Hospital's Outpatient Clinic
Official Title
Effectiveness of Lung Impedance Guided Preemptive Therapy of Chronic Heart Failure Patients With Preserved Ejection Fraction (LVEF ≥ 45%) in Our Hospital's Outpatient Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We aim to determine the effectiveness of lung impedance guided preemptive therapy (LI-Guided) of chronic heart failure patients with preserved ejection fraction (LVEF ≥ 45%) who are being treated in our hospital's outpatient clinic.
Detailed Description
Protocol Impedance HFpEF study Eligible patients are: older than 18 years, had a left ventricle ejection fraction (LVEF) > 45% with New York Heart Association (NYHA) functional class II-IV, and have been hospitalized for Heart Failure within 12 months of recruitment . The study requires optimal medical therapy for HF according to current guidelines. Patients have to be followed for at least 12 months. Exclusion criteria are: implantation of a cardiac resynchronization device within the preceding 3 months and the presence of advanced chronic kidney disease (estimated glomerular filtration rate <25 mL/min per 1.73 m2). All patients provided written informed consent. Randomization is: 1:1 to the active LI-guided treatment arm where clinicians are unblinded to LI values and could base therapy on LI level during outpatient clinic visits. In the control arm LI values are recording but not conveying to the clinical treatment team. In the case of hospitalization, LI is also recorded but this information was not provided to the treating physician. However, once patients resumed in hospital care LI was again provided to the treatment team only if the patient is assigned to the actively LI-guided group.
Inpatient study protocol At each out hospital visit such parameters as: vital signs, weight, jugular venous pressure (JVP), leg edema (0-4 points according to the level of lower limb edema), extent of lung rales (0- no rales, 1- basilar rales, 2- up to 1/3 of the lower lung field, 3- up to 1/2 of the lower lung field, 4- rales beyond half of the lung field) and oximetry were recorded, and NYHA class assessed. Chest radiographs (CXR) were performed at hospital admission and discharge. JVP was graded according to a modified Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial scale, i.e., maximal level of venous pulsation above sternal angle < 3 cm was defined as JVP= 0, a level of 3-5 cm as JVP= 1, 5-8 cm as JVP= 2, 8-11 cm as JVP = 3 and level of venous head> 11 cm as JVP = 4 are registered. NT-pro BNP level is measured at admission and discharge. CXRs and NT-pro BNP samples were used to substantiate the cause of admission, the degree of pulmonary congestion and extent of improvement during hospitalization. The 10-point radiological score (RS) was applied to assess the CXR when RS=0 signifies no congestion; RS of 1-4 represents interstitial congestion; and RS of 5-10 is compatible with alveolar edema. Medical therapy administered during hospitalization has to be documented.
This information is correct up to December 31, 2017. To date, there have been 24 participants in the interventional arm of the study and 24 in the control group.
Study update June 17, 2020: To date we have enrolled 102 patients (51 patients in each arm). The data monitoring committee of the study has reviewed the ongoing results and has allowed its continuation to the following year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LI-Guided Therapy
Arm Type
Experimental
Arm Description
One hundred and fifty chronic heart failure patients treated based on guidelines and LI-Guided Therapy.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
One hundred and fifty chronic heart failure patients treated based on guidelines only.
Intervention Type
Other
Intervention Name(s)
LI-Guided Therapy
Intervention Description
Preemptive treatment according to LI monitoring
Intervention Type
Other
Intervention Name(s)
Heart Failure Guidelines
Intervention Description
Treatment according to clinical signs
Primary Outcome Measure Information:
Title
Reduced all cause, cardiovascular, and heart failure hospitalizations
Time Frame
Five years
Title
Reduced mortality
Time Frame
Five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients hospitalized within past 12 months for heart failure
Exclusion Criteria:
Dialysis patients
Patients with GFR <25
Patients with serious illness and life expectancy <12
Mentally incompetent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Shochat, MD, PhD
Phone
972-4-630-4491
Email
shochat1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Shochat, MD, PhD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Shochat, MD, PhD
Phone
972-4-630-4491
Email
shochat@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Lung Impedance Guided Preemptive Therapy of Chronic Heart Failure Patients With Preserved Ejection Fraction (LVEF ≥ 45%) in Our Hospital's Outpatient Clinic
We'll reach out to this number within 24 hrs