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

NCT04441203 | Recruiting DMC

• 1 other identifier: MHICC-2018-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Time to the first occurrence of the individual components of the primary endpoint

  12 months

• Number of Participants with CV death

  12 months

• Change in Quality of life

  12 months

• Change in functional capacity between baseline and 12-months

  12 months

• Change in 6 minutes walk distance

  12 months

Study Arms (2)

Control

NO INTERVENTION

Heart failure clinic follow up

CardioMems

ACTIVE COMPARATOR

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

Interventions

CardioMems DEVICE

novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System

CardioMems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Study Officials

• Anique Ducharme

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Jean Rouleau, MD

  Montreal Heart Institute

  STUDY DIRECTOR

Central Study Contacts

Anique Ducharme, MD

CONTACT

5143763330; anique.ducharme@umontreal.ca

Hélène Brown, BSc CCRP

CONTACT

5143763330; helene.brown@icm-mhi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc. Director of the Heart Failure clinic

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 22, 2020
• Study Start: May 4, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)