Health Condition 1: I501- Left ventricular failure, unspecified
Conditions
Interventions
None listed
Sponsors
Turtle Shell Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient is 18 years or older Patient diagnosed with heart failure(HF) and classified as stage II-III as per New York Heart Association Classification Patient with less than or equal to 40 percent left ventricular ejection fraction (LVEF), measured by echocardiography(ECHO) Elevated Nterminal prohormone -type natriuretic peptide (NT-proBNP) at baseline is greater than 400 picogram/millilitre Patient should be able to reach out to his treating physician/hospital within 3 hours, when necessary Patient has adequate facility at home to support the Dozee home monitoring set up
Exclusion criteria
Exclusion criteria: Patientâ??s health condition is not stable enough for home monitoring Patient has been advised to undergo procedure/intervention in hospital within the next 30 days Patient is receiving regular care at the hospital such as dialysis, frequent hospital visits for terminal illness/ emergency department visits or chemotherapy Patient is not able to lie flat on the bed surface Patient is pregnant or nursing Patient is enrolled in any other clinical trial Patient has an impairment that as judged by the investigator does not allow the subject to independently follow rules and procedures of the protocol Patient has uncontrolled seizures or other neurological disorders leading to excessive abnormal movements or tremors in the upper body Patient has severe pulmonary disease, including chronic obstructive pulmonary disease (stage C/D), uncontrolled asthma, severe pulmonary hypertension (World Health Organization class III-IV
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are -To evaluate the patientâ??s perception of the benefit of the CCC program. -To evaluate the doctorâ??s perception of the benefit of the CCC program. Timepoint: 90 days | — |
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to evaluate the validity of DHI red alerts to indicate worsening of health status in CHF patients. Timepoint: At the end of 90 days from baseline | — |
Countries
India
Contacts
Public ContactPooja Kadambi
Turtle Shell Technologies
Outcome results
None listed