AuthorisedTherapeutic use (Phase IV)Interventional

REstoration with calcifediol of VItamin D deficiency in pulmonary Arterial Hypertension patients (REVIDAH study)

This study, called REVIDAH, is for people in the UK who have Pulmonary Arterial Hypertension (PAH). This is a serious condition where there's high blood pressure in the arteries that go from your heart to your lungs. We're looking at whether a specific form of vitamin D, called calcifediol, can improve the health of people with PAH. We will also check if it's safe. The study focuses on certain types of PAH, including those that are inherited, caused by drugs, or linked to connective tissue diseases. It's a 'Phase IV' study, meaning it's looking at how a treatment already used for other things works for this condition in real-world settings.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Consorci Mar Parc De Salut De Barcelona

Enrolment target

102

Start

02 Sep 2025

hereditary drug- and toxin-induced PAH or associated to connective tissues disease

What is this study about?

This study, known as REVIDAH, is exploring a new way to potentially help people living with Pulmonary Arterial Hypertension (PAH). PAH is a serious condition where the blood vessels in your lungs become narrowed, making it harder for your heart to pump blood through them. This can lead to symptoms like breathlessness, tiredness, and chest pain.

Researchers want to see if supplementing with a special form of vitamin D, called calcifediol, can make a difference for people with PAH. Many people with PAH also have low vitamin D levels, and scientists are keen to understand if correcting this might improve their overall health. This study is considered a 'Phase IV' trial, which means it's testing a treatment that's already known and approved for other uses, but now we're looking at its effects specifically for PAH.

The main goal is to find out if vitamin D can lead to improvements in symptoms and prevent the condition from getting worse. We will also carefully check if the vitamin D treatment is safe and doesn't cause unwanted side effects.

Key takeaways

This study investigates if vitamin D can help people with high blood pressure in their lungs.
It focuses on specific types of Pulmonary Arterial Hypertension (PAH).
Both men and women aged 18 and over can participate.
Participation involves taking medication and attending regular clinic visits for tests.
The main goals are to see if health improves and if the treatment is safe.
Results could lead to new ways to manage PAH.

Who may be eligible?

This study is looking for adults aged 18 or older, and welcomes both men and women to take part.

To be eligible, you must have a diagnosis of Pulmonary Arterial Hypertension (PAH). Specifically, this includes PAH that: * Occurs without a known cause (idiopathic) * Is inherited from family (hereditary) * Is caused by certain medications or toxins * Is linked to other conditions like connective tissue diseases (for example, lupus or scleroderma).

If you have one of these types of PAH, you might be able to join. Your doctor can help determine if your specific condition fits the study's requirements.

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 a diagnosis of Pulmonary Arterial Hypertension (PAH)?
Is your PAH considered idiopathic, hereditary, drug- or toxin-induced, or linked to connective tissue disease?
Are you willing to take a study medication and attend regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given calcifediol, which is a form of vitamin D, or a similar-looking dummy pill (placebo). You will take these pills regularly as instructed.

You will have several visits to the clinic where the research team will monitor your health. These visits will involve various tests, such as blood tests to check your vitamin D levels and other markers, and a 'six-minute walk test', which measures how far you can walk in six minutes. They will also assess your overall well-being, lung pressure, and quality of life through questionnaires.

The study will follow your progress over a certain period to understand how the medication affects your health. The medical team will explain the exact schedule of visits and tests during the consent process.

Potential risks and benefits

Participating in this study might offer potential benefits, such as very close monitoring of your PAH and potentially improving your condition if the vitamin D supplement proves effective. However, there's no guarantee of personal benefit, and the calcifediol might not help your PAH. As with any medication, there are potential risks, including side effects from the calcifediol, which the research team will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is Pulmonary Arterial Hypertension (PAH)?

PAH is a serious condition where the blood pressure in your lungs is too high, making it hard for your heart to pump blood.

What is calcifediol?

Calcifediol is a specific form of vitamin D that researchers are testing in this study.

What does a 'six-minute walk test' involve?

It's a simple test where you walk as far as you can in six minutes, to measure your exercise ability.

Will I definitely get the vitamin D supplement?

Participants will either receive calcifediol or a dummy pill (placebo). Neither you nor the doctors will know which you are getting until the study ends.

What is a Phase IV study?

A Phase IV study looks at a treatment that is already approved for other uses, to see how it works for a new condition in real-world patients.