Chronic Heart FailureSELFIe-HFNCT04441203
Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes
A study testing CardioMems in people with Chronic Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- CardioMems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 21Show fewer
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Christine Henri, MD, 514-376-3330 ext. 3947, henri_christine@hotmail.com
Helene Brown, RN. B.Sc., 514-376-3330 ext. 3931, helene.brown@icm-mhi.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- CardioMems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMemsDevice
novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CardioMems |
What is being measured
The primary outcome is the main question the study is designed to answer.
first occurrence of any component of the composite event
acute decompensated heart failure requiring emergency department consultation
Measured: 12 months
Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic
unplanned intravenous heart failure therapy in an outpatient clinic
Measured: 12 months
Number of Participants with hospital admission for heart failure
hospital admission for heart failure
Measured: 12 months
Number of Participants with cardiovascular (CV) death
cardiovascular (CV) death
Measured: 12 months
Secondary outcomes (9)
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
Measured: 12 months
Number of Participants with CV death
CV death
Measured: 12 months
Change in Quality of life
Quality of life questionnaire
Measured: 12 months
Change in functional capacity between baseline and 12-months
NYHA functional class (Kansas city cardiomyopathy questionnaire)
Measured: 12 months
Change in 6 minutes walk distance
6 minutes walk distance test
Measured: 12 months
Number of Participants with device-related endpoints
Safety: adverse events related to the device
Measured: 12 months
Number of successful patient contacts
Number of successful patient contacts
Measured: 12 months
Pulmonary artery pressures changes mesured by the CardioMems device
Pulmonary artery pressures changes mesured by the CardioMems device
Measured: 12 months
Cost-effectiveness
cost-effectiveness ratio
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start4 May 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anique Ducharme, Montreal Heart Institute
- Investigators
- Anique Ducharme, Principal investigator, Montreal Heart InstituteJean Rouleau, MD, Study director, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441203
- Sponsor's protocol ID
- MHICC-2018-001
- Acronym
- SELFIe-HF
- Status last verified
- Nov 2024
- First submitted
- 12 Jun 2020
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes (the SELFIe-HF Trial): Program
- ClinicalTrials.gov ID
- NCT04441203
- Acronym / sponsor ID
- SELFIe-HF / MHICC-2018-001
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Heart failure clinic follow up |
| CardioMems | Active comparator | Device: CardioMemsThe treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioMemsnovel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System | Device | CardioMems |
Primary outcome
first occurrence of any component of the composite event
Time frame: 12 months
acute decompensated heart failure requiring emergency department consultation
Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic
Time frame: 12 months
unplanned intravenous heart failure therapy in an outpatient clinic
Number of Participants with hospital admission for heart failure
Time frame: 12 months
hospital admission for heart failure
Number of Participants with cardiovascular (CV) death
Time frame: 12 months
cardiovascular (CV) death
9 secondary outcomes
Time to the first occurrence of the individual components of the primary endpoint
Time frame: 12 months
Number of Participants with CV death
Time frame: 12 months
Change in Quality of life
Time frame: 12 months
Change in functional capacity between baseline and 12-months
Time frame: 12 months
Change in 6 minutes walk distance
Time frame: 12 months
Number of Participants with device-related endpoints
Time frame: 12 months
Number of successful patient contacts
Time frame: 12 months
Pulmonary artery pressures changes mesured by the CardioMems device
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anique Ducharme principal investigator
Montreal Heart Institute
Jean Rouleau, MD study director
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioMems in people with Chronic Heart Failure, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anique Ducharme, MD (5143763330 ext. 3947, anique.ducharme@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first occurrence of any component of the composite event (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.