Heart Disease Trial, Recruiting NCT04441203 Sponsor: Montreal Heart Institute Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT04441203
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older, of any gender
  • People with heart failure who have had at least one hospital admission for heart failure in the past 12 months, with moderate symptoms (confirm with trial site for exact symptom classification)
  • People with heart failure who have had at least one emergency room visit or unplanned clinic visit needing intravenous water tablets in the past 12 months, AND have a specific elevated blood protein marker (NT-proBNP above 800 pg/ml), AND have mild-to-moderate or moderate-to-severe heart failure symptoms while already taking water tablets (furosemide 40mg or more daily)
  • People who have had reduced or preserved heart pumping function for at least 3 months
  • People who have basic ability to use a smartphone or tablet, including access to the internet
  • People whose pulmonary artery (a blood vessel in the lungs where a small device would be placed) measures between 7mm and 15mm in diameter — and for people with a BMI over 35, the distance from their back to that blood vessel must be less than 10cm (confirm with trial site)

Who may not be able to join:

  • People who have had a recent heart attack, a heart procedure to open blocked arteries, a new or revised heart rhythm device implanted, a device lead removed, major heart or other surgery, a mini-stroke, or a stroke within the past 2 months (or within 3 months for certain heart surgeries or a specific type of heart rhythm device)
  • People who have heart surgery already planned or scheduled
  • People with a history of blood clots in the lungs or repeated blood clots in the legs
  • People with the most severe level of heart failure symptoms that have not improved, those with an artificial heart pump implanted, or those expected to receive a heart transplant within 12 months
  • People with severe narrowing of a heart valve, an infection of the heart, a specific thickening of the heart muscle that blocks blood flow, recent heart muscle inflammation, fluid around the heart, or a large collection of fluid around the heart
  • People who are considered too medically unstable to be monitored remotely, including those with a resting blood pressure below 80 or above 180 mmHg, a resting heart rate above 100 beats per minute, or severely reduced kidney function (or kidneys that do not respond to water tablets, or people on dialysis)
  • People with severely high blood pressure in the lungs (systolic pulmonary artery pressure of 80 mmHg or above)
  • People with high lung blood pressure caused by reasons other than heart failure (confirm with trial site)
  • People with anaemia (low red blood cell levels) who need blood transfusions, iron infusions, or who have a haemoglobin level below 100
  • People with blood clotting disorders, those who cannot safely pause blood-thinning medication, or those who cannot take blood-thinning or antiplatelet medicines as required by the trial
  • People who cannot tolerate aspirin or clopidogrel (common blood-thinning medicines)
  • People with an active infection currently being treated with antibiotics
  • People who are unwilling to sign a consent form or attend outpatient clinic visits
  • People currently taking part in another research trial that involves a treatment or intervention
  • People who have been discharged to a long-term care facility or who live too far from the trial site
  • Women who are pregnant, breastfeeding, or who are able to become pregnant and are not using an accepted form of contraception (such as the contraceptive pill, an intrauterine device, or surgical sterilisation)
  • People with any other condition that, in the treating doctor's judgement, could affect how well the trial results can be measured, affect safety, reduce ability to follow the trial requirements, or who have a life expectancy of less than one year

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Anique Ducharme, Montreal Heart Institute

Phone: 5143763330

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Montreal Heart Institute
Registry
ClinicalTrials.gov
Start date
4 May 2020
Est. completion
1 December 2025

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

first occurrence of any component of the composite event; Number of Participants with unplanned intravenous heart failure therapy in an outpatient clinic; Number of Participants with hospital admission for heart failure; Number of Participants with cardiovascular (CV) death

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov