Actively Recruiting
Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes
Led by Montreal Heart Institute · Updated on 2024-11-22
150
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Symptomatic heart failure (NYHA class III) with at least one heart failure hospitalization in the past 12 months
- Or at least one emergency visit or unplanned heart failure clinic visit requiring intravenous diuretics in the last 12 months with NT-proBNP level above 800 pg/ml and NYHA class II on diuretics (furosemide ≥ 40 mg daily), III, or ambulatory IV
- Heart failure with reduced or preserved ejection fraction lasting at least 3 months
- Basic knowledge of smartphone or iPad use and internet access for self-management application
- Pulmonary artery branch diameter between 7 mm and 15 mm
- If BMI is over 35, distance from patient's back to target pulmonary artery less than 10 cm
You will not qualify if you...
- Recent cardiovascular event within 2 months such as acute coronary syndrome, PCI, new cardiac device implantation or revision, lead extraction, major surgery, transient ischemic attack, or stroke
- Scheduled cardiac surgery
- History of pulmonary embolism or recurrent deep vein thrombosis
- Persistent NYHA class IV and advanced heart failure stage D, ventricular assist device implantation, or listed for cardiac transplantation likely within 12 months
- Severe valve disease, endocarditis, obstructive hypertrophic cardiomyopathy, acute myocarditis, tamponade, or large pericardial effusion
- Clinically unstable for remote follow-up including resting blood pressure <80 or >180 mmHg, resting heart rate >100 bpm, advanced kidney disease or dialysis
- Severe pulmonary hypertension with systolic pulmonary artery pressure ≥80 mmHg
- Pulmonary hypertension other than group II
- Anemia requiring transfusions, iron therapy, or hemoglobin below 100
- Coagulopathy or contraindications to antiplatelet/anticoagulant treatments
- Intolerance to aspirin or clopidogrel
- Active infection requiring systemic antibiotics
- Unwillingness to sign informed consent or attend outpatient clinic
- Participation in another interventional research trial
- Discharge to chronic care facility or residence in outlying area
- Pregnant or lactating women or women of childbearing potential not using accepted contraception
- Any condition risking safety, efficacy evaluation, or poor adherence including cognitive decline
- Life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
Research Team
A
Anique Ducharme, MD
CONTACT
H
Hélène Brown, BSc CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here