Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (the SELFIe-HF Trial): Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Montreal Heart Institute
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Number of Participants with cardiovascular (CV) death
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Anique Ducharme
MD, MSc. Director of the Heart Failure clinic
Montreal Heart Institute
Eligibility Criteria
Inclusion Criteria
- •Male or female ≥ 18 years old.
- •Symptomatic HF (NYHA III) with recent heart failure admission in the previous year (12 months). OR
- •Patient with at least one ER visit or unplanned HF clinic requiring iv diuretics within 12 months will be eligible if they have in addition a N-terminal pro-BNP (NT-proBNP) level \> 800pg/ml at screening AND NYHA Class II on diuretics (furosemide ≥ 40mg qd), III or ambulatory IV.
- •HF with reduced or preserved EF of at least 3 months duration.
- •Minimum technological knowledge either with a smartphone or iPAD for use of the self-management application, including access to internet.
- •Anatomical criteria
- •PA branch diameter between 7 mm - 15 mm
- •For BMI \>35, distance from patient's back to target PA\<10cm
Exclusion Criteria
- •Recent cardiovascular event: Acute coronary syndrome (STEMI/NSTEMI; a small rise in the troponin level would be expected in this population and is not a contraindication for enrolment); Percutaneous Coronary Intervention (PCI), new cardiac rhythm management (CRM) device (pacemaker, ICD and CRT), CRM system revision, lead extraction or cardiac or other major surgery or transient ischemic attack or stroke within 2 months (3 months of stabilization after CRT or cardiac surgery);
- •Scheduled cardiac surgery;
- •History of pulmonary embolism or recurrent deep vein thrombosis;
- •Persistent NYHA Class IV and ACC/AHA HF Stage D, patients implanted with a ventricular assist device (VAD), or patients listed for cardiac transplantation and likely to be transplanted within 12 months;
- •Coexisting severe stenotic valve lesions, endocarditis, obstructive hypertrophic cardiomyopathy, acute myocarditis, tamponade, or large pericardial effusion;
- •Clinically too unstable to be followed remotely; this includes but is not limited to:
- •Resting systolic blood pressure \< 80 or \> 180 mmHg;
- •Resting heart rate \> 100 bpm;
- •Stage IV or V chronic kidney disease (Estimated Glomerular Filtration Rate (eGFR) that remains \< 30 mL/min/1.73m2 by MDRD) or nonresponsive to diuretic therapy or on chronic renal dialysis;
- •Severe pulmonary hypertension with systolic pulmonary artery pressure ≥80 mmHg;
Outcomes
Primary Outcomes
Number of Participants with cardiovascular (CV) death
Time Frame: 12 months
cardiovascular (CV) death
Number of Participants with hospital admission for heart failure
Time Frame: 12 months
hospital admission for heart failure
first occurrence of any component of the composite event
Time Frame: 12 months
acute decompensated heart failure requiring emergency department consultation
Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic
Time Frame: 12 months
unplanned intravenous heart failure therapy in an outpatient clinic
Secondary Outcomes
- Number of Participants with CV death(12 months)
- Change in Quality of life(12 months)
- Number of successful patient contacts(12 months)
- Cost-effectiveness(12 months)
- Pulmonary artery pressures changes mesured by the CardioMems device(12 months)
- Time to the first occurrence of the individual components of the primary endpoint(12 months)
- Number of Participants with device-related endpoints(12 months)
- Change in functional capacity between baseline and 12-months(12 months)
- Change in 6 minutes walk distance(12 months)