Not yet recruitingNAINTERVENTIONAL

VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure)

This study, called VINDICATE 2, is investigating if daily vitamin D supplements can improve the health of people living with chronic heart failure who also have low vitamin D levels. Participants will be randomly assigned to take either an active vitamin D supplement (4000 units daily) or a placebo (a dummy pill) for at least two and up to four years. The researchers want to see if vitamin D can reduce hospital stays for heart failure or even lower the risk of death. The study is designed to be very careful, with neither the patients nor their doctors knowing who is getting the real vitamin D, to ensure fair results. Information will be collected from NHS records and patient questionnaires to understand the supplement's effects on well-being and overall health.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Leeds

Enrolment target

1,253

Start

01 Dec 2023

Estimated completion

01 Mar 2027

Chronic Heart Failure

What is this study about?

This research study, known as VINDICATE 2, is trying to find out if daily vitamin D supplements can help people who have long-term heart failure. Heart failure means your heart isn't pumping blood as well as it should, which can make you feel tired and out of breath. The study is specifically for those with a certain type of heart failure called 'LVSD' and who also have low levels of vitamin D in their blood.

For this study, some participants will take a vitamin D supplement (4000 units every day), while others will take a 'placebo' – a dummy pill that looks exactly like the vitamin D but contains no active medicine. This is done so researchers can fairly compare what happens to both groups. Neither you nor your doctor will know whether you're taking the active vitamin D or the placebo, which helps ensure the results are as unbiased as possible.

The main goal is to see if taking vitamin D can reduce the number of times people with heart failure need to go into hospital or even lower their risk of dying. Researchers will also look at other things like overall health, how participants feel in their daily lives, and the potential cost-effectiveness of using vitamin D as a treatment. This information will help doctors understand if vitamin D could become a useful additional treatment for heart failure patients in the future.

Key takeaways

The study tests if vitamin D helps people with long-term heart failure and low vitamin D.
Participants take either vitamin D or a dummy pill daily for 2-4 years.
Neither you nor your doctor will know which pill you are taking.
The main aim is to see if vitamin D reduces hospital stays or improves survival.
Annual check-ups and questionnaires will be part of the study.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have long-term heart failure where the left side of their heart isn't working as well as it should (called LVSD). You must have been on stable treatment for your heart failure, including any devices you might have, for at least three months. Importantly, you also need to have low vitamin D levels in your blood to be considered.

Additionally, to join the study, you'll need to meet at least one of these extra conditions: you've been in hospital for heart failure in the last year, you take a high dose of a water tablet (like Furosemide), you have diabetes, or your heart failure is caused by problems with your blood vessels (ischaemic heart disease).

There are also some reasons why you wouldn't be able to join. For example, if you can't or don't want to give your consent, have severe memory problems, severe lung disease (COPD), anaemia, or another serious illness that could shorten your life. Also, if you have certain conditions like active sarcoidosis or tuberculosis, you wouldn't be eligible.

Quick self-check

Are you 18 years old or older?
Do you have chronic heart failure (LVSD) and have been on stable treatment for at least 3 months?
Do you know if you have low vitamin D levels?
Have you been in hospital for heart failure in the last year, or do you take a high dose of water tablets, or do you have diabetes, or is your heart failure due to blood vessel issues?
Are you able to agree to take part in the study?
Do you have any other very serious health conditions that might prevent you from joining?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will take one pill every day – either a vitamin D supplement or a dummy pill – for at least two years, and potentially up to four years. You won't know which one you're taking, and neither will your doctor, to keep the study fair.

You will have check-ups at the hospital, likely once a year, where researchers will ask you to fill out questionnaires about how you're feeling and how your heart failure affects your daily life. They will also collect information about your health from your NHS records. This includes details about any hospital stays and your overall health, which will be securely transferred for analysis. The total time you'll be part of the study could be anywhere from two to four years.

Potential risks and benefits

Taking part in this study may or may not directly benefit you. We hope that vitamin D might improve your heart health and reduce hospital stays, but this is what the study aims to discover. There are some potential risks with any medication, even supplements, though the dose of vitamin D used is generally considered safe. However, serious side effects are rare. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Leeds General Infirmary
Leeds, United Kingdom

Common questions

What is chronic heart failure?

Chronic heart failure means your heart isn't pumping blood as effectively as it should, leading to symptoms like tiredness and shortness of breath that develop over time.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It's used in studies to fairly compare a new treatment against no treatment.

Why don't I know if I'm getting the vitamin D or the placebo?

This is called a 'blinded' study. It helps ensure that neither you nor your doctor's expectations influence the results, making the study's findings more reliable.

How long would I need to be in the study?

You would be part of the study for a minimum of two years and a maximum of four years, depending on how long it takes for the study to gather enough information.

Will taking part affect my current heart failure treatment?

No, this study is designed for patients who are already on stable and optimal treatment for their heart failure. The vitamin D supplement would be in addition to your current care.

How to find out more

Klaus K Witte, MD

k.k.witte@leeds.ac.uk Official trial record

Always speak to your GP or specialist before deciding to take part in a study.