Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02173548
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2014-06-20
Brief Title:
Interleukin-1 Blockade in HF With Preserved EF
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Interleukin-1 Blockade in Heart Failure With Preserved Ejection Fraction HFpEF a Randomized Placebo-controlled Double Blinded Study D-HART2
Status:
COMPLETED
Status Verified Date:
2018-05
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:
D-HART2
Brief Summary:
Heart Failure with Preserved Ejection Fraction HFpEF is a common form of heart failure
Standard treatment for heart failure show less than ideal results in HFpEF
Evidence of systemic inflammation is common in all forms of heart failure including HFpEF
The main hypothesis of this study is that systemic inflammation contributes to heart failure symptoms and exercise limitations in patients with HFpEF
The main objective is to treat patients with HFpEF and evidence of systemic inflammation with an anti-inflammatory drug targeting Interleukin-1 or placebo to determine effects on cardiovascular function
Standard treatment for heart failure show less than ideal results in HFpEF
Evidence of systemic inflammation is common in all forms of heart failure including HFpEF
The main hypothesis of this study is that systemic inflammation contributes to heart failure symptoms and exercise limitations in patients with HFpEF
The main objective is to treat patients with HFpEF and evidence of systemic inflammation with an anti-inflammatory drug targeting Interleukin-1 or placebo to determine effects on cardiovascular function
Detailed Description:
Heart Failure with Preserved Ejection Fraction HFpEF is a common form of heart failure characterized by symptoms of congestion and impaired exercise tolerance secondary to impaired left ventricular filling diastole in absence of a significant impairment in contractility LVEF50 or significant valvular abnormalities shunts or intra- or extra-cavitary obstruction
The standard treatment for patient with heart failure is very effective in Heart Failure with Reduced Ejection Fraction HFrEF but it not very effective in HFpEF
Evidence of systemic inflammation is common in all forms of heart failure including HFpEF and predicts worse outcomes C reactive protein CRP is the preferred inflammatory biomarker used as risk predictor for cardiovascular disease Patients with heart failure HFpEF or HFrEF with elevated CRP levels are more likely to be severely limited by heart failure symptoms are more likely to be admitted to the hospital for heart failure and are more likely to die of cardiac causes
Preclinical studies show that a key mediator of systemic inflammation Interleukin-1 IL-1 impairs cardiac and vascular function and may contribute to the pathogenesis of heart failure
The main hypothesis of this study is that systemic inflammation and IL-1 in particular contributes to heart failure symptoms and exercise limitations in patients with HFpEF
The main objective is to treat patients with HFpEF and evidence of systemic inflammation with an IL-1 blocker anakinra recombinant human IL-1 receptor antagonistor placebo to determine effects on exercise capacity measured as peak oxygen consumption at maximal cardiopulmonary exercise testing
The standard treatment for patient with heart failure is very effective in Heart Failure with Reduced Ejection Fraction HFrEF but it not very effective in HFpEF
Evidence of systemic inflammation is common in all forms of heart failure including HFpEF and predicts worse outcomes C reactive protein CRP is the preferred inflammatory biomarker used as risk predictor for cardiovascular disease Patients with heart failure HFpEF or HFrEF with elevated CRP levels are more likely to be severely limited by heart failure symptoms are more likely to be admitted to the hospital for heart failure and are more likely to die of cardiac causes
Preclinical studies show that a key mediator of systemic inflammation Interleukin-1 IL-1 impairs cardiac and vascular function and may contribute to the pathogenesis of heart failure
The main hypothesis of this study is that systemic inflammation and IL-1 in particular contributes to heart failure symptoms and exercise limitations in patients with HFpEF
The main objective is to treat patients with HFpEF and evidence of systemic inflammation with an IL-1 blocker anakinra recombinant human IL-1 receptor antagonistor placebo to determine effects on exercise capacity measured as peak oxygen consumption at maximal cardiopulmonary exercise testing
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 |
|---|---|---|---|
| 1R34HL118348-01A1 | NIH | None | httpsreporternihgovquickSearch1R34HL118348-01A1 |