Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04677608
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2020-12-16
Brief Title:
Pulmonary Hypertension Modality of Death and Validation of REVEAL Risk Score
Sponsor:
iPHNET italian Pulmonary Hypertension NETwork
Organization:
iPHNET italian Pulmonary Hypertension NETwork
Study Overview
Official Title:
An Italian Multicenter Prospective Study on Pulmonary Hypertension Modality of Death and Validation of Reveal Risk Score
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASPYRE-1
Brief Summary:
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
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
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 130000 and 260000 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 eg 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 andor 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
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 eg 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None