Status:
RECRUITING
Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes
Lead Sponsor:
Montreal Heart Institute
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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: hospita...
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 acc...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04441203
Start Date
May 4 2020
End Date
December 1 2025
Last Update
November 22 2024
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8