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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: CardioMems

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anique Ducharme, MD; Phone Number: 3947 5143763330; Email: anique.ducharme@umontreal.ca
• Study Contact Backup: Name: Hélène Brown, BSc CCRP; Phone Number: 3931 5143763330; Email: helene.brown@icm-mhi.org

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Recruiting
      • Montreal Heart Institute
      • Contact: Christine Henri, MD; Phone Number: 3947 514-376-3330; Email: henri_christine@hotmail.com
      • Contact: Helene Brown, RN. B.Sc.; Phone Number: 3931 514-376-3330; Email: helene.brown@icm-mhi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Investigators: Principal Investigator: Anique Ducharme, Montreal Heart Institute; Study Director: Jean Rouleau, MD, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MHICC-2018-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No