Virtual Heart Failure Clinic for Patient Self-Management

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

This study is testing if a virtual Heart Failure Clinic using a special sensor to monitor heart health can help people manage their condition better than regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montreal Heart Institute (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT04441203 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a virtual Heart Failure Clinic that utilizes Pulmonary Artery Pressure monitoring for patient self-management against traditional care methods. Participants will be randomized into two groups: one receiving the CardioMEMS HF sensor for remote hemodynamic monitoring and the other receiving usual care from a specialized heart failure clinic. The study will evaluate outcomes such as hospital admissions, emergency department visits, and cardiovascular death over a 12-month period. The trial is designed to assess both the clinical benefits and cost-effectiveness of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic heart failure (NYHA Class II or III) who have had at least one hospitalization or emergency visit for heart failure in the past year.

Not a fit: Patients with recent cardiovascular events or those who do not meet the anatomical criteria for the CardioMEMS sensor may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce hospital admissions and improve management of chronic heart failure for patients.

How similar studies have performed: Other studies have shown promising results with remote monitoring approaches in heart failure management, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female ≥ 18 years old.
2. Symptomatic HF (NYHA III) with recent heart failure admission in the previous year (12 months). OR
3. 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.
4. HF with reduced or preserved EF of at least 3 months duration.
5. Minimum technological knowledge either with a smartphone or iPAD for use of the self-management application, including access to internet.
6. Anatomical criteria

   1. PA branch diameter between 7 mm - 15 mm
   2. For BMI \>35, distance from patient's back to target PA\<10cm

Exclusion Criteria:

1. 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);
2. Scheduled cardiac surgery;
3. History of pulmonary embolism or recurrent deep vein thrombosis;
4. 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;
5. Coexisting severe stenotic valve lesions, endocarditis, obstructive hypertrophic cardiomyopathy, acute myocarditis, tamponade, or large pericardial effusion;
6. Clinically too unstable to be followed remotely; this includes but is not limited to:

   1. Resting systolic blood pressure \< 80 or \> 180 mmHg;
   2. Resting heart rate \> 100 bpm;
   3. 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;
7. Severe pulmonary hypertension with systolic pulmonary artery pressure ≥80 mmHg;
8. Pulmonary hypertension other than group II PH;
9. Anemia requiring transfusions, iron infusions, or hemoglobin below 100;
10. Coagulopathy or uninterruptible anticoagulation therapy or contraindication to antiplatelet/anticoagulant treatments anticipated in the protocol;
11. Intolerance to aspirin or clopidogrel;
12. Active infection requiring systemic antibiotics;
13. Unwillingness to sign informed consent or to attend the outpatient clinic;
14. Participation in another research trial with intervention;
15. Discharge to a chronic care facility or residence in an outlying area;
16. 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
17. 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.
18. Life expectancy \<1 year;

Where this trial is running

Montreal, Quebec

• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Anique Ducharme — Montreal Heart Institute
• Study coordinator: Anique Ducharme, MD

Conditions Chronic Heart Failure