To demonstrate that a virtual Heart Failure Clinic (HFC) based on patient self-management using Pulmonary Artery Pressure (PAP) monitoring is superior to usual care of HFC, leads to decreased: hospital admissions for heart failure (HF), emergency department consultation and/or unplanned intravenous heart failure therapy and cardiovascular death, compared to a regular HFC, has low device-related complications and is cost-effective, in New York Heart Association (NYHA) class III and II (requiring diuretics) patients.
This will be a single center, prospective, randomized, open-label blinded-endpoint (PROBE) trial in which the treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group. Patients with at least one hospitalization for HF (≥1) in the previous year (12 months) will be randomized into two groups, regardless of LVEF: Usual care with the specialized multidisciplinary HF clinic team (Non-implanted Control) or Hemodynamic monitoring, less intense HF clinic follow-up, and remote follow-up by a nurse clinician and patient empowerment with access to the PAP data (CardioMEMS group). Primary and secondary endpoints will be compared between groups after 12 months of follow-up and within groups comparing baseline parameters with 12 month follow-up measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System
Montreal Heart Institute
Montreal, Quebec, Canada
RECRUITINGfirst occurrence of any component of the composite event
acute decompensated heart failure requiring emergency department consultation
Time frame: 12 months
Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic
unplanned intravenous heart failure therapy in an outpatient clinic
Time frame: 12 months
Number of Participants with hospital admission for heart failure
hospital admission for heart failure
Time frame: 12 months
Number of Participants with cardiovascular (CV) death
cardiovascular (CV) death
Time frame: 12 months
Time to the first occurrence of the individual components of the primary endpoint
Acute decompensated heart failure that requires emergency department consultation and/or unplanned intravenous heart failure therapy in an outpatient clinic
Time frame: 12 months
Number of Participants with CV death
CV death
Time frame: 12 months
Change in Quality of life
Quality of life questionnaire
Time frame: 12 months
Change in functional capacity between baseline and 12-months
NYHA functional class (Kansas city cardiomyopathy questionnaire)
Time frame: 12 months
Change in 6 minutes walk distance
6 minutes walk distance test
Time frame: 12 months
Number of Participants with device-related endpoints
Safety: adverse events related to the device
Time frame: 12 months
Number of successful patient contacts
Number of successful patient contacts
Time frame: 12 months
Pulmonary artery pressures changes mesured by the CardioMems device
Pulmonary artery pressures changes mesured by the CardioMems device
Time frame: 12 months
Cost-effectiveness
cost-effectiveness ratio
Time frame: 12 months
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