Active not recruitingNAINTERVENTIONAL

Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

Many people waiting for a kidney transplant have regular heart checks to find hidden heart problems. This is because heart disease is a big concern for transplant patients. However, we don't fully know if all these extra checks are truly helpful, or if they sometimes cause unnecessary worry or procedures. This study, called CARSK, wants to find out if reducing these regular checks for heart problems after your first assessment is as good as the current system. We're looking at whether this change affects serious heart events, how many people actually get a transplant, and if it saves money for the healthcare system. The goal is to make sure patients get the best care while waiting for their new kidney.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

3,306

Start

01 Dec 2018

Estimated completion

26 Jan 2028

Cardiovascular Diseases End Stage Renal Disease Kidney Transplantation Dialysis Related Complication

What is this study about?

If you're waiting for a kidney transplant, you might know that heart health is extra important. Heart problems are unfortunately very common for people with kidney disease, both while they are on the transplant waiting list and after they get a new kidney. Because of this, it's standard practice to regularly check for hidden heart disease, even if you don't have any symptoms.

The idea behind these checks is to find any potential heart issues early so they can be treated, perhaps with an operation or a procedure to clear blocked arteries. This is done to prevent serious heart problems from happening, especially around the time of your transplant. It also helps make sure that a precious donated kidney goes to someone who is most likely to benefit from it in the long term. However, these regular checks can be expensive, time-consuming, and sometimes lead to procedures that might not always be necessary or even have their own risks.

The CARSK study wants to look closely at whether all these regular heart checks are truly needed. We know that you'll have an initial heart check when you first go on the waiting list. This study will compare what happens if you don't have further regular heart checks after that first one, versus continuing with the standard regular checks. The main goal is to see if skipping these extra checks is just as safe and effective in preventing major heart problems. The study will also look at how these different approaches affect your chances of getting a transplant and if they make the healthcare system more efficient.

Key takeaways

This study evaluates how often people waiting for a kidney transplant need heart checks.
It compares fewer routine checks to the current regular screening practice.
The main aim is to see if less screening is just as safe for preventing serious heart problems.
The study also looks at how screening affects getting a transplant and healthcare costs.
Participation will not change your regular kidney disease or transplant care.

Who may be eligible?

This study is looking for adults aged 18 or older who have serious kidney disease and are either being assessed for a kidney transplant or are already on the waiting list. You must be expected to need more heart checks under the current usual care system, and you should be able to give your informed consent to take part. Also, it's expected that you will likely be waiting for a transplant for more than a year from when you join the study. This helps us see the long-term effects of the different approaches.

There are certain situations where you wouldn't be able to join. For example, if you have signs of an uncontrolled heart condition, like serious chest pain, severe heart failure, or heart rhythm problems. You also can't take part if you've been put on hold for a transplant due to another medical issue, or if you've had other organ transplants in the past. People who are planning to get a kidney from a living donor, or those who need multiple organ transplants (like a kidney and pancreas), won't be suitable for this study either. It's really important that you are able to understand the study and agree to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have serious kidney failure and are you on, or being assessed for, the kidney transplant waiting list?
Do you expect to need more routine heart checks under the current system?
Are you able to understand the study and agree to take part?
Do you expect to wait for a kidney transplant for more than a year?

Answer every question to see your result.

What does participation involve?

The study aims to compare two different ways of monitoring your heart health while you're on the kidney transplant waiting list. You'll either continue with the regular heart checks that are currently standard practice (like having them every 1-2 years), or you'll have fewer regular heart checks after your initial assessment to join the waiting list. You won't know which group you're in until you join the study, as it's decided by chance. The medical team will keep a close eye on your health throughout, and you will continue to have all your usual care related to your kidney disease and transplant journey. This is a long-term study, as it follows you while you are waiting for your transplant, and we expect that you would be on the waiting list for more than 12 months from when you join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be helping to guide future kidney transplant care, making the process safer and more efficient for everyone. For those in the reduced screening group, it might mean fewer medical appointments and tests, which could reduce stress and save time. However, the exact impact on your personal health is what the study is trying to understand, so there's no guarantee of a personal benefit. For those in the regular screening group, you continue with care that is currently considered standard. There's always a small risk with any medical procedure or test, but these are part of standard care. Importantly, you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (22)

University of Arizona
Verified postcode
Tucson, United States
The George Washington University
Verified postcode
Washington D.C., United States
University of Alberta
Verified postcode
Edmonton, Canada
University of British Columbia
Verified postcode
Vancouver, Canada
Dalhousie University
Verified postcode
Halifax, Canada
St. Joseph's Healthcare
Verified postcode
Hamilton, Canada
Kingston Health Science Centre
Verified postcode
Kingston, Canada
London Health Science Centre
Verified postcode
London, Canada
The Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada
University Health Network
Verified postcode
Toronto, Canada
St Michael's Hospital
Verified postcode
Toronto, Canada
CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec
Verified postcode
Laval, Canada

Common questions

What is the main question this study is trying to answer?

It wants to know if having fewer routine heart checks while waiting for a kidney transplant is as safe as having regular checks.

Why is heart health so important for transplant patients?

Heart problems are a leading cause of illness and death for people with kidney disease, both before and after a transplant.

Will I still get my normal kidney care?

Absolutely. Taking part in this study won't change your regular care for your kidney disease or your transplant journey.

What if I get symptoms of a heart problem during the study?

If you develop any new heart symptoms, your medical team will assess and treat you as they normally would, regardless of which study group you are in.

How long will I be in the study?

You'll be followed while you are on the transplant waiting list. The study expects participants to be waiting for more than a year.