Prognostic Value of Vitamin D and Intact Parathyroid Hormone (iPTH) in Pulmonary Hypertension

NCT06872710 | Not Yet Recruiting

• 3 other identifiers: 14/2023REHAPREHAR
• Study Type: observational
• Target: 345
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this observational study is to analyse the prognostic value of 25(OH)-vitamin D, iPTH and other serum biomarkers in patients with pulmonary hypertension. Serum samples are obtained from the Spanish Biobank of pulmonary hypertension. Clinical data will be collected from the Spanish registries on pulmonary hypertension (REHAP and REHAR).

Conditions

Pulmonary Hypertension

Keywords

Vitamin D; iPTH; hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Survival

  The main end-point of the study is to analyze whether the levels of the serum biomarker predicts survival as analyzed by a Kaplan-Meier analysis and statistically compared using the log-rank test.

  Events (deaths) will be analyzed from the blood sample extraction until March 1st 2025.

Secondary Outcomes (2)

• Survival (hazard risk) and transplant-free survival

  Events (death or transplant) will be analyzed from the blood sample extraction until March 1st 2025.

• Clinical risk factors

  Parameters will be obtained from the registry at the nearest date within six months of the date of plasma sampling in the Biobank

Study Arms (4)

Control

46 anonymized serum samples from controls without any known cardiovascular disease collected at the Biobank, matched by sex and age with the other cohorts. All the available samples were recruited. This group is used to compare the biomarker levels in healthy individuals.

Pulmonary arterial hypertension (group 1 PH)

170 anonymized serum samples from patients with pulmonary arterial hypertension, including patients with idiopathic PAH (87), heritable PAH (5), drug-induced PAH (8), PH associated to connective tissue disease (27), PH associated to portal hypertension (12), associated ot congenital heart disease (31). Samples were randomly selected by the Biobank administrators with the only condition that they had not been previously analyzed by us.

Chronic thromboembolic pulmonary hypertension (group 4 PH)

100 anonymized serum samples from patients with chronic thromboembolic pulmonary hypertension.

Pulmonary hypertension associated to Chronic Respiratory Disease or hypoxia (group 3 PH)

30 anonymized serum samples from patients with CRD-associated PH. All the available samples were recruited.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed of PH (groups 1, 3 and 4) which have donated serum samples to the Spanish Biobank of PH. All these patients are included in the Spanish registries of PH (REHAP for groups 1 and 4, REHAR for group 3) Samples available in the Biobank from controls who have donated serum and have no known cardiovascular disease.

You may not qualify if:

• Samples from PAH associated to HIV infection, schistosomiasis or PAH with features of venous/capillary (PVOD/PCH) involvement.
• Samples from patients that were analyzed in our previous study (PMID: 32041235)

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Hospital Clinic of Barcelona: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Hypertension, Pulmonary; Hyperparathyroidism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Francisco Perez Vizcaino, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Perez Vizcaino, PhD, Full professor

CONTACT

34-913941464; fperez@med.ucm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 13 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 12, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 28, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share