Clinical trial NCT02661841: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduced all cause, cardiovascular, and heart failure hospitalizations
timeFrame: Five years
measure: Reduced mortality
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Michael Shochat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: