- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04677608
Pulmonary Hypertension Modality of Death and Validation of REVEAL Risk Score (ASPYRE-1)
An Italian Multicenter Prospective Study on Pulmonary Hypertension Modality of Death and Validation of Reveal Risk Score
Pulmonary Arterial Hypertension (PAH) is a chronic disease characterized by a progressive increase in pulmonary vascular resistance (PVR), which leads to right ventricular (RV) failure, and ultimately death.
Different studies have outlined how various factors as vascular resistance, functional class, age, correlate with mortality. However, the modality of death and risk factors for mortality in patients with PAH are little known. For this purpose, more studies are necessary to analyze the risk factors related to modality of death in PAH.
Study Overview
Status
Conditions
Detailed Description
Pulmonary Arterial Hypertension (PAH) is a disease characterized by dyspnea, fatigue, chest pain, and syncope. PAH results from a narrowing of the small arteries and arterioles, resulting in elevation of pulmonary vascular resistance and leading to the development of right ventricular failure and death if untreated. Worldwide, it is estimated that between 130,000 and 260,000 persons have PAH. Mean age at diagnosis is 35 years, and most patients present with moderate-to-severe disease. PAH occurs most often in otherwise healthy persons, and more often in women than men. There is no known cure for PAH, and the goal of current therapy is to control symptoms of the disease and hopefully slow its progression. Prognosis is poor in patients with PAH, and is similar to that of many advanced cancers; five-year survival in the absence of treatment is only about 50%.
Comparatively little is known about the modality of death and risk factors for mortality in patients with PAH. In a recent systematic review, a little consensus was found among the 54 studies identified, most of which involved relatively few patients.
Of 107 risk factors that were found to be significantly related to mortality in at least one study, only 10 demonstrated "a reproducible predictive association with mortality." Benza and colleagues recently reported on a retrospective analysis of information from 2716 PAH patients enrolled in the US Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL). This study was much larger than any previous one and too recent to be included in the aforementioned systematic review. In multivariate analysis, they found that high pulmonary vascular resistance (PVR >32 Wood Units), PAH secondary to portal hypertension, NYHA Functional Class IV, male gender, older age (>60 years), and family history of PAH were all predictive of 1-year mortality. Interestingly, none of the 107 risk factors identified in the systematic review concerned nutritional status (e.g., body mass index [BMI], serum albumin). Preliminary results from an ongoing European study, however, suggest that low BMI is an important independent predictor of mortality in patients with PAH, possibly including death due to chronic heart failure, sudden cardiac death, and/or death due to extracardiac causes. If this is indeed the case, then improvements inpatient nutrition may offer the potential to extend life expectancy at the relatively low burden and minimal cost.
Given current uncertainty about the mode of death and risk factors for mortality in PAH, a new study is planned to examine this issue, with a particular focus on the independent contribution of BMI as a risk factor for mortality.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Rome, Italy, 00161
- Recruiting
- Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I
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Contact:
- Carmine Dario Vizza, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of PAH (group 1) according to ESC/ERS classification
Exclusion Criteria:
- Diagnosis of one of the following groups of PH:
- Group 1: PAH associated with congenital heart disease
- Group 2: PH due to left heart disease
- Group 3: PH due to lung disease and/or hypoxia
- Group 4: Chronic Thromboembolic PH (CTEPH)
- Group 5: PH due to miscellaneous causes
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modality of death
Time Frame: two years
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to identify the different modality of death in patients with PAH
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two years
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Risk factors
Time Frame: two years
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to identify risk factors for mortality in patients with PAH
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two years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASPYRE-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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