Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients

Launched by SENSIBLE MEDICAL INNOVATIONS LTD. · May 14, 2015

Keywords

ClinConnect Summary

The study is designed as a prospective, randomized, controlled, multi-center trial. Patients will be enrolled during an index hospitalization for Acutely decompensated Heart Failure (ADHF) and will be followed for a minimum of 3 months or a maximum of 9 months (until the last patient has completed the 3- month follow-up). Patients will be blinded to ReDS readings values.

Recruitment will take place either during a heart failure hospitalization (see acceptance criteria below) or within 10 days after discharge from a qualifying heart failure hospitalization.

The Remote Dielectric Sensing (R...

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • 1. Patient has signed informed consent and authorization to use and disclose health information.
• • 2. Patient's physical condition enables him to sit up and lay down with minimal assistance.
• • 3. Diagnosis of HF, with preserved or reduced LVEF, was made at least 30 days prior to enrollment.
• • 4. Patients with LVEF \<40% must have been treated at least 30 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contra-indicated) and an ACE-inhibitor or ARB (unless intolerant or contra-indicated).
• • 5. Patient is hospitalized for ADHF requiring significant alteration in heart failure treatment (i.e. diuretics or vasoactive drugs) or up to 10 days post-discharge from an ADHF admission.
• • 6. BNP ≥ 350 pg/ml (NT pro BNP \> 1400 pg/ml) at enrollment (within 24h) and/or ≥750 pg/ml any time during the hospital stay (NT-pro BNP \>3000 pg/ml).
• • Note that if a patient is enrolled during a clinic visit rather than during a hospitalization, then the BNP from the index admission is referenced.
• Main Exclusion Criteria:
• • 1. Patient has had a cardiac transplantation or VAD implantation.
• • 2. CRT implantation within 90 days prior to screening or planned implantation during study duration.
• • 3. Current or past Pulmonary Embolism in the right lung. Notes: (i) Past pulmonary emboli are defined as identified \<6 months prior to enrollment. (ii) past or current tiny, microscopic pulmonary emboli do not exclude a patient. (iii) if a ventilation-perfusion (VQ) scan shows that the lungs are clear, then the exclusion criteria is not met.
• • 4. Diagnosis of Severe Pulmonary Hypertension.
• • 5. STEMI and or CABG within 30 days of screening visit. Note: Type 2 MI due to ADHF is not an exclusion.
• • 6. Chronic renal failure with CrCl\<25mL/min, as calculated by the Cockcroft-Gault formula.
• • 7. Chronic home IV therapy or cardiac inotropes or diuretics
• • 8. Physical deformity in the thorax area or lesion that may prevent proper vest application or adjustment (Severe scoliosis/ sensitive sternotomy lesion etc.).
• • 9. Illness/ Condition which may be aggravated or cause significant discomfort by the application of the vest (Rib fractures, with or without flail chest, Severe Osteoporosis).
• • 10. Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.
• 11. Patient's habitus out of range due to one or more of the following:
• • Height less than 155cm or higher than 195cm (5.1; 6.4 feet respectively).
• • BMI of less than 22 or more than 36. In case of BMI between 36-38, if the measured vest ruler is not \>=4, the exclusion criteria is met.
• • 12. Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (Dextrocardia, Lung Carcinoma etc.) including pacemaker box on the right side of the chest.
• • 13. Severe COPD, defined as chronic and continuous home use of O2 (O2 dependancy) and/ or oral steroids. Continuous is defined as 24hours a day, every day.
• • 14. Severe disease / conditions with life expectancy \<6 months according to investigator's assessment.
• • 15. Patient is enrolled in another interventional study with permission of study manager (observational or registries are not excluded).
• • 16. Patient HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, Weight scale, BNP or bioimpedance).
• • 17. Prisoners and ward of the state