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.
Auf einen Blick
Worum geht es in dieser Studie?
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.
Wichtige Erkenntnisse
- 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.
Wer könnte berechtigt sein?
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.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Sind Sie 18 Jahre alt oder älter?
- 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?
Was beinhaltet die Teilnahme?
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.
Potenzielle Risiken und Vorteile
Standorte (1)
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Häufige Fragen
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.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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