REstoration of VItamin D in Pulmonary Arterial Hypertension

Launched by PARC DE SALUT MAR · Feb 6, 2024

Keywords

ClinConnect Summary

The clinical trial titled "REstoration of VItamin D in Pulmonary Arterial Hypertension" is studying whether restoring vitamin D levels can help improve symptoms and overall health in patients with pulmonary arterial hypertension (PAH) who also have a severe deficiency of vitamin D. PAH is a serious condition that affects blood flow in the lungs and can lead to heart problems. Many patients with PAH also have low levels of vitamin D, which could make their condition worse. The researchers believe that giving patients a vitamin D supplement called calcifediol might help improve their health and well-being.

To participate in this trial, you must be between 18 and 75 years old, diagnosed with PAH, and have very low vitamin D levels. You should also be stable on your current PAH medications and not have certain other health issues. If you qualify and decide to join, you will be randomly assigned to receive either the vitamin D supplement or a placebo (a non-active treatment) for 24 weeks. Throughout the study, the researchers will monitor your health to see if there are improvements in your symptoms. This study is not yet recruiting participants, but it aims to find a simple and low-cost way to help patients with PAH feel better and improve their quality of life.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients aged 18 -75 years.
• • 2. Patients with diagnosis of PAH of the following types according to 2022 ERS/ESC guidelines: idiopathic, hereditary, drug and toxin-induced PAH or associated to connective tissues disease.
• • 3. Patients who are stable and treated with standard medications for PAH on monotherapy or with combinations of drugs, including calcium channel blockers, phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERA), prostacyclin analogues or selexipag or with stable dose of diuretics who had no treatment modification for at least 6 weeks before randomization.
• • 4. Patients with an intermediate-low and intermediate-high risk score according to 2022 ERS/ESC guidelines.
• • 5. Patients with severe deficiency of vitamin D, defined herein as plasma or serum 25(OH)vitamin D levels equal to or lower than 12 ng/ml
• • 6. Patients who can understand and follow instructions, and who are able to participate in the study for the entire study.
• • 7. Patients must have given their written informed consent to participate in the study after having received adequate previous information and before any study-specific procedures.
• Exclusion Criteria:
• • 1. Participation in another interventional clinical study within 30 days before screening.
• • 2. Previous randomisation to treatment during this study (no re-randomisation).
• • 3. Pregnant women or breastfeeding women, or women with childbearing potential not using a effective contraception method throughout the study.
• • 4. Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate in or complete this study, in the opinion of the investigator.
• • 5. Patients with substance abuse (eg, alcohol or drug abuse) within the previous 3 months before and at randomisation.
• • 6. Patients with underlying medical disorders with an anticipated life expectancy \<2 years.
• • 7. Patients with a history of severe allergies or multiple drug allergies or with hypersensitivity to the investigational drug or any of the excipients.
• • 8. Patients unable to perform a valid 6MWD test (eg, orthopaedic disease or peripheral artery occlusive disease that affects the patient's ability to walk).
• • 9. Excluded medication/treatment: active treatment with digoxin.