Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (the SELFIe-HF Trial): Program

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: CardioMems


Participation Criteria
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Eligibility Criteria
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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; Pulmonary hypertension other than group II PH; Anemia requiring transfusions, iron infusions, or hemoglobin below 100; Coagulopathy or uninterruptible anticoagulation therapy or contraindication to antiplatelet/anticoagulant treatments anticipated in the protocol; Intolerance to aspirin or clopidogrel; Active infection requiring systemic antibiotics; Unwillingness to sign informed consent or to attend the outpatient clinic; Participation in another research trial with intervention; Discharge to a chronic care facility or residence in an outlying area; Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception, such as the oral contraceptive pill, an intrauterine device or surgical sterilization. If necessary a negative urine or blood test will be performed before randomization Any condition that in the opinion of the investigator would jeopardize the evaluation for efficacy or safety or be associated with poor adherence to the protocol, including cognitive decline. Life expectancy <1 year;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Heart failure clinic follow up | |
| Active Comparator: CardioMems<br>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. | Device: CardioMems<br>* novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first occurrence of any component of the composite event | acute decompensated heart failure requiring emergency department consultation | 12 months | 
| Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic | unplanned intravenous heart failure therapy in an outpatient clinic | 12 months | 
| Number of Participants with hospital admission for heart failure | hospital admission for heart failure | 12 months | 
| Number of Participants with cardiovascular (CV) death | cardiovascular (CV) death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| Number of Participants with CV death | CV death | 12 months | 
| Change in Quality of life | Quality of life questionnaire | 12 months | 
| Change in functional capacity between baseline and 12-months | NYHA functional class (Kansas city cardiomyopathy questionnaire) | 12 months | 
| Change in 6 minutes walk distance | 6 minutes walk distance test | 12 months | 
| Number of Participants with device-related endpoints | Safety: adverse events related to the device | 12 months | 
| Number of successful patient contacts | Number of successful patient contacts | 12 months | 
| Pulmonary artery pressures changes mesured by the CardioMems device | Pulmonary artery pressures changes mesured by the CardioMems device | 12 months | 
| Cost-effectiveness | cost-effectiveness ratio | 12 months |