Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01881971
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2013-04-02
Brief Title:
Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center
Sponsor:
Alison Morris
Organization:
University of Pittsburgh
Study Overview
Official Title:
Multicenter Prospective Adaptive Response Placebo-controlled Double-blind Study Comparing Effects of Rosuvastatin Versus Placebo
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
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:
SPARC
Brief Summary:
Hypothesis Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV
Detailed Description:
Growing evidence indicates that chronic obstructive pulmonary disease COPD is an important cause of respiratory impairment in HIV persons and will likely increase as the HIV population continues to age In the HIV-uninfected population COPD frequently co-exists with cardiac disease including atherosclerosis and pulmonary hypertension PH The investigators work has demonstrated that a syndrome of cardiopulmonary dysfunction exists even in non-smoking or antiretroviral-treated HIV individuals The investigators have found that HIV individuals have a high prevalence of respiratory symptoms airflow obstruction and diffusing capacity DLco abnormalities that occur concurrently with cardiac co-morbidities including radiographic measures of atherosclerosis and elevated echocardiographic pulmonary artery pressures This syndrome is marked by inflammation with elevated levels of cytokines and hsCRP peripheral T-cell activation and increased sputum neutrophils as well as elevation of NT-proBNP a marker of heart strain Importantly the investigators have shown that DLco impairment and elevated NT-proBNP are significant independent predictors of mortality in HIV indicating that cardiopulmonary dysfunction is likely highly clinically relevant and identifies a vulnerable population in whom the investigators lack effective interventions
Statins have anti-inflammatory effects in the lung and vasculature that might benefit cardiopulmonary dysfunction in HIV These agents have a long history of clinical use in cardiovascular disease and are currently being investigated as disease-modifying drugs for HIV COPD and PH In preliminary analyses the investigators have found that HIV individuals who received statin therapy within the past year were significantly less likely to have impaired DLco and had lower pulmonary artery pressures lower NT-proBNP lower peripheral cytokines and fewer sputum neutrophils despite being older and having a greater smoking history than those not using statins
Statins have anti-inflammatory effects in the lung and vasculature that might benefit cardiopulmonary dysfunction in HIV These agents have a long history of clinical use in cardiovascular disease and are currently being investigated as disease-modifying drugs for HIV COPD and PH In preliminary analyses the investigators have found that HIV individuals who received statin therapy within the past year were significantly less likely to have impaired DLco and had lower pulmonary artery pressures lower NT-proBNP lower peripheral cytokines and fewer sputum neutrophils despite being older and having a greater smoking history than those not using statins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RFA-HL-12-034 | OTHER_GRANT | NHLBI | None |