By: Allison Currie
Cape Breton has reached a global milestone, providing local patients with access to cutting-edge cardiology care through clinical research. This achievement further cements Nova Scotia’s growing reputation as a leader in healthcare innovation.
A research team in Cape Breton, led by Dr. Paul MacDonald, cardiologist at Cape Breton Regional Hospital, has secured a global First Subject In (FSI) for the AstraZeneca Prevent HF clinical trial, surpassing 34 other countries to enroll the world’s first patient.
This groundbreaking cardiology trial is investigating a new drug designed to delay the onset of heart failure in at-risk patients, including those with cardiovascular disease, type 2 diabetes, and hypertension. It’s focus on prevention offers a unique perspective - setting it apart as a key differentiator in clinical studies currently happening in Nova Scotia.
This milestone builds on Nova Scotia Health’s longstanding partnership with AstraZeneca, with Cape Breton already serving as a site for multiple active clinical trials with the company.
Dr. MacDonald is well versed in conducting clinical trials and has been actively involved in them for the 25 years he’s lived in Sydney, Nova Scotia. He credits his success to the local community and his dedicated team.
“We have an engaged, generous and courageous population willing to participate in clinical trials and other studies,” says Dr. MacDonald. “While I help select and screen participants, much of the work is done by our team, including managers and research assistants who have more direct contact. Success in trials leads to more opportunities, and we've consistently met targets and maintained a high retention rate, ensuring complete follow-up with participants.”
A strong team is vital to the success of these trials, as establishing a study like AstraZeneca Prevent HF is no quick feat. The trial was first proposed six to twelve months ago, undergoing extensive reviews to assess whether the team had the necessary resources, as well as a thorough review of safety and ethical considerations - while simultaneously managing other ongoing studies.
When the trial was ready to begin in March, the team consented a patient within 90 minutes of being informed they were open for enrollment. Over the next year, twelve to fifteen additional patients will be enrolled, with these participants followed for four to five years until enough data is gathered to determine whether the treatment is successful.
We sat down with Dr. MacDonald to learn more about the study and what it means for the province.
What will the AstraZeneca Prevent HF clinical trial entail?
For treating heart failure patients, one of four major pieces of goal directed therapy is a drug called Spironolactone, which is a mineral corticoid receptor antagonist. The drug involved in this study is a similar drug that works further upstream in the biological pathway. The goal of the trial is to see if, instead of treating heart failure, we can prevent heart failure from developing. Patients who've had a heart attack, who might also have diabetes or high blood pressure, are at very high risk for developing heart failure, so we're treating those patients to see if we can prevent them from developing heart failure down the road. For that reason, it's a very long patient trial. It means we have to recruit patients, have potential events occur, and then have events prevented.
But success of the trial could have a big impact because congestive heart failure is one of the most common causes for hospital admission in Nova Scotia and those patients tend to be very sick, needing very long lengths of stay.
What does It mean for patients in Nova Scotia and beyond?
At the Cape Breton Regional Hospital, we would see roughly 400 heart attacks a year. Half of those patients would have diabetes, and most would also have hypertension. We would also see over 500 admissions per year with congestive heart failure. So, there are a lot of candidates for this type of treatment, who would then normally stay in hospital for ten to twelve days or more. If we can prevent 100 hospital admissions and 1000 hospital days of stay, then those numbers can add up quickly, leading to better patient outcomes, shorter wait times and less strain on the system.
What makes Cape Breton appealing as a clinical trial site?
I think our site is appealing for a few reasons.
First, because of the success my team has had previously with clinical trials.
Second, patients here have been incredibly generous and supportive when we've asked them to consider enrolling in trials.
Third, it’s critical that these trials don’t enroll patients exclusively from large, well-resourced hospitals or academic institutions in the United States, as the results may not reflect the realities of care in rural communities. It’s important to have diversity, women, rural vs city, etc. represented in clinical trials so that we can also apply the successful results to a broad population.
Why is participation in research important?
Patient participation in research is how we learn what treatments are appropriate for patients. This is how we arrive at the course of treatment if you’re having a heart attack, congestive heart failure, hypertension, stroke or any disease process you can identify. Good medicine comes from good clinical trials. So, it's important for Nova Scotians and Canadians to be participating in these trials, so we can apply the results to our patients sooner, ultimately improving patient outcomes.
Research is care, and clinical studies help translate research into potentially life-changing therapies that can help you, your friends and your loved ones. Want to know more about how to get involved? Visit Nova Studies Connect today: novastudiesconnect.ca
