Pulmonary HypertensionNBHAPNCT06872710
Prognostic Value of Vitamin D and Intact Parathyroid Hormone (iPTH) in Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by Universidad Complutense de Madrid.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 28 Dec 2025
- How long will I take part?
- 13 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prognostic Value of Vitamin D and IPTH in Pulmonary Hypertension
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).
Read the detailed description
Background. Pulmonary hypertension (PH) is a heterogeneous pathophysiological condition characterized by progressive pulmonary vascular narrowing that ultimately results in right-sided heart failure and eventually death or lung transplantation.
Pulmonary arterial hypertension (PAH, group 1 PH), PH associated to chronic respiratory diseases or hypoxia (CRDPH, group 3 PH) and chronic thromboembolic pulmonary hypertension (CTEPH, group 4) are subgroups of pulmonary hypertension.
The effectiveness of current pharmacological treatments is suboptimal and a large proportion of patients still had events or died despite receiving combination therapy. Vitamin D deficiency has been found to be much more frequent in PAH patients than in the general population or even compared to patients with other severe cardiovascular diseases. Our previous study (PMID: 32041235) showed that PAH deficiency has a negative prognostic impact in three subgroups of PAH (idiopathic, heritable and drug-induced). Animal studies support that vitamin D deficiency worsens PAH.
Serum samples are available from the Spanish Biobank of pulmonary hypertension in IDIBAPS (Hospital Clinic, Barcelona) which has collected and stored samples from Spanish PH patients since 2013. The samples are anonymized and linked to clinical data, which are recorded in the registries REHAP (group 1 and 4 PH) and REHAR (group 3 PH) and are continuously updated.
Biomarkers, including, but not limited, to 25-OH-vitamin D and iPTH, will be measured in the samples using commercial ELISA kits. These measured values will be related to the clinical variables. Patients will be classified according to the biomarker levels. The analysis of the Receiver operating characteristic (ROC) curve will be performed and the optimal cutoff values for biomarkers levels will be chosen based for each biomarker.
The main end-point of the study is to analyze whether the levels of a given serum biomarker predicts survival as analyzed by a Kaplan-Meier analysis and statistically compared using the log-rank test.
Secondary end-points. The Cox's proportional hazards model will be also used to include additional covariates. Additional variables that will be compared: 6-min walking distance, tricuspid annular plane systolic excursion (TAPSE), B-type natriuretic peptide (BNP) and the N-terminal fragment of pro-BNP (NT-pro-BNP) levels, New York Heart Association (NYHA) functional class, the non-invasive risk score (PMID: 28775050).
Two-sample comparisons will be analyzed using Mann-Whitney test for non normal continuous variables, t-test for normal continuous variables, and exact Fisher test or chi-square for trends for NYHA functional class or risk assessment. Data will be presented as scatter plots and medians. A p-value less than 0.05 will be considered statistically significant.
This is a collaborative study within the Ciberes Network Francisco Pérez Vizcaíno (Univ Complutense) Isabel Blanco (IDIBAPS) Rui Adao (Univ Complutense)
- Conditions
- Pulmonary Hypertension
- Keywords
- Vitamin D, iPTH, hyperparathyroidism
- Medical subject headings
- Hypertension, Pulmonary, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
There are no interventions. Samples were collected by the Biobank since 2013.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Events (deaths) will be analyzed from the blood sample extraction until March 1st 2025.
Secondary outcomes (2)
Survival (hazard risk) and transplant-free survival
Survival will also be analyzed using the Cox's proportional hazards model to analyze potential co-variates.
To analyze whether the levels of the serum biomarker predicts transplant-free survival as analyzed by a Kaplan-Meier analysis and statistically compared using the log-rank test.
Measured: Events (death or transplant) will be analyzed from the blood sample extraction until March 1st 2025.
Clinical risk factors
Additional variables that will be compared: 6-min walking distance, tricuspid annular plane systolic excursion (TAPSE), B-type natriuretic peptide (BNP), the N-terminal fragment of pro-BNP (NT-pro-BNP) levels, New York Heart Association (NYHA) functional class and the non-invasive risk score (PMID: 28775050).
Two-sample comparisons will be analyzed using Mann-Whitney test for non normal continuous variables, t-test for normal continuous variables, and exact Fisher test or chi-square for trends for NYHA functional class or risk assessment. Data will be presented as scatter plots and medians. A p-value less than 0.05 will be considered statistically significant.
Measured: Parameters will be obtained from the registry at the nearest date within six months of the date of plasma sampling in the Biobank
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 345 participants (estimated)
- Target duration
- 13 Years
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Francisco Pérez Vizcaíno, Universidad Complutense de Madrid
- Investigators
- Francisco Perez Vizcaino, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872710
- Sponsor's protocol ID
- 14/2023
- Other IDs
- REHAP, REHAR
- Acronym
- NBHAP
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The clinical data is available in the registries REHAP and REHAR. The access to these data requires an application.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Vitamin D and IPTH in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06872710
- Acronym / sponsor ID
- NBHAP / 14/2023
- Conditions
- Pulmonary Hypertension
- Keywords
- Vitamin D, iPTH, hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background. Pulmonary hypertension (PH) is a heterogeneous pathophysiological condition characterized by progressive pulmonary vascular narrowing that ultimately results in right-sided heart failure and eventually death or lung transplantation.
Pulmonary arterial hypertension (PAH, group 1 PH), PH associated to chronic respiratory diseases or hypoxia (CRDPH, group 3 PH) and chronic thromboembolic pulmonary hypertension (CTEPH, group 4) are subgroups of pulmonary hypertension.
The effectiveness of current pharmacological treatments is suboptimal and a large proportion of patients still had events or died despite receiving combination therapy. Vitamin D deficiency has been found to be much more frequent in PAH patients than in the general population or even compared to patients with other severe cardiovascular diseases. Our previous study (PMID: 32041235) showed that PAH deficiency has a negative prognostic impact in three subgroups of PAH (idiopathic, heritable and drug-induced). Animal studies support that vitamin D deficiency worsens PAH.
Serum samples are available from the Spanish Biobank of pulmonary hypertension in IDIBAPS (Hospital Clinic, Barcelona) which has collected and stored samples from Spanish PH patients since 2013. The samples are anonymized and linked to clinical data, which are recorded in the registries REHAP (group 1 and 4 PH) and REHAR (group 3 PH) and are continuously updated.
Biomarkers, including, but not limited, to 25-OH-vitamin D and iPTH, will be measured in the samples using commercial ELISA kits. These measured values will be related to the clinical variables. Patients will be classified according to the biomarker levels. The analysis of the Receiver operating characteristic (ROC) curve will be performed and the optimal cutoff values for biomarkers levels will be chosen based for each biomarker.
The main end-point of the study is to analyze whether the levels of a given serum biomarker predicts survival as analyzed by a Kaplan-Meier analysis and statistically compared using the log-rank test.
Secondary end-points. The Cox's proportional hazards model will be also used to include additional covariates. Additional variables that will be compared: 6-min walking distance, tricuspid annular plane systolic excursion (TAPSE), B-type natriuretic peptide (BNP) and the N-terminal fragment of pro-BNP (NT-pro-BNP) levels, New York Heart Association (NYHA) functional class, the non-invasive risk score (PMID: 28775050).
Two-sample comparisons will be analyzed using Mann-Whitney test for non normal continuous variables, t-test for normal continuous variables, and exact Fisher test or chi-square for trends for NYHA functional class or risk assessment. Data will be presented as scatter plots and medians. A p-value less than 0.05 will be considered statistically significant.
This is a collaborative study within the Ciberes Network Francisco Pérez Vizcaíno (Univ Complutense) Isabel Blanco (IDIBAPS) Rui Adao (Univ Complutense)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 13 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There are no interventions. Samples were collected by the Biobank since 2013. | Other | Chronic thromboembolic pulmonary hypertension (group 4 PH), Control, Pulmonary arterial hypertension (group 1 PH), Pulmonary hypertension associated to Chronic Respiratory Disease or hypoxia (group 3 PH) |
Primary outcome
Survival
Time frame: Events (deaths) will be analyzed from the blood sample extraction until March 1st 2025.
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.
2 secondary outcomes
Survival (hazard risk) and transplant-free survival
Time frame: Events (death or transplant) will be analyzed from the blood sample extraction until March 1st 2025.
Clinical risk factors
Time frame: Parameters will be obtained from the registry at the nearest date within six months of the date of plasma sampling in the Biobank
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No. The clinical data is available in the registries REHAP and REHAR. The access to these data requires an application.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco Perez Vizcaino, PhD principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Universidad Complutense de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Perez Vizcaino, PhD, Full professor (34-913941464, fperez@med.ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Events (deaths) will be analyzed from the blood sample extraction until March 1st 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.