Recruiting NA Cardiovascular Diseases

New treatment option for Cardiovascular Diseases

Official title The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.

ClinicalTrials.gov ID: NCT06919302

What this study is testing

What it's testing
Despite the availability of medications, many people around the world continue to live with long-term health problems like heart disease, stroke and diabetes. In Canada, heart disease is a leading cause of death.
  • 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 45 and older

You may be able to join if

  • Be taking statin medication with or without other antihyperlipidemic therapy (stable dose for at least 3-months).
  • Fall under either of the 2 categories: 1) Secondary prevention participants: males and females ≥45 years of age with established atherosclerotic...
  • Be on a stable dose for at least 3-months of all antihyperlipidemic, antihyperglycemic, antihypertensive, and antiobesity therapies.
  • Have a family physician in Ontario and a valid Ontario Health Card.
  • Have regular access to an online portal

You likely can't join if

  • Major disease expected to result in death within 2 years (except cardiovascular disease)
  • Active sever liver disease
  • Malabsorption disorders
  • Drug or alcohol abuse disorders (within past 6 months)
  • Intolerance or allergies to soy protein and tree nuts, peanuts, or seeds
  • Planned coronary intervention or any major surgical procedure
See the full eligibility criteria
Who can join
  • Be taking statin medication with or without other antihyperlipidemic therapy (stable dose for at least 3-months).
  • Fall under either of the 2 categories: 1) Secondary prevention participants: males and females ≥45 years of age with established atherosclerotic cardiovascular disease (ASCVD) defined as at least one of the following...
  • Be on a stable dose for at least 3-months of all antihyperlipidemic, antihyperglycemic, antihypertensive, and antiobesity therapies.
  • Have a family physician in Ontario and a valid Ontario Health Card.
  • Have regular access to an online portal
  • Be proficient in English.
What rules you out
  • Major disease expected to result in death within 2 years (except cardiovascular disease)
  • Active sever liver disease
  • Malabsorption disorders
  • Drug or alcohol abuse disorders (within past 6 months)
  • Intolerance or allergies to soy protein and tree nuts, peanuts, or seeds
  • Planned coronary intervention or any major surgical procedure
  • Participation in another clinical trial (within past 3 months)
  • End stage renal disease (requirement for peritoneal dialysis or hemodialysis for renal insufficiency or eGFR \<30 mL/min)
  • Any condition or therapy which might pose a risk to the patient or make participation in the study not be in the best interest of the patient as assessed by the investigator
  • Documented severe (New York Heart Association [NYHA] class IV) heart failure
  • Mental/psychological impairment expected to affect adherence to the study protocol
  • Known AIDS (HIV-positive patients without AIDS are allowed)
  • Women planning on becoming pregnant within the first year of the intervention
  • Unable to provide informed consent: Appear unable to comprehend the study protocol during the interview process or to understand and communicate in English sufficiently for informed consent.

The study team makes the final eligibility decision.

Where it's taking place

  • Toronto, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 45 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Toronto, Ontario, 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.