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New treatment option for Chronic Heart Failure
Official title Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes
ClinicalTrials.gov ID: NCT04441203
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join if
- Recent cardiovascular event: Acute coronary syndrome (STEMI/NSTEMI; a small rise in the troponin level would be expected in this population and is...
- 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...
- Coexisting severe stenotic valve lesions, endocarditis, obstructive hypertrophic cardiomyopathy, acute myocarditis, tamponade, or large pericardial...
- Clinically too unstable to be followed remotely; this includes but is not limited to:
See the full eligibility criteria
- 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...
- 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
- 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...
- 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 \ 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...
- Any condition that in the opinion of the investigator would jeopardize the evaluation for how well it works or safety or be associated with poor adherence to the protocol, including cognitive decline.
- Life expectancy \<1 year;
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.