Ignite Creation Date:
2024-05-06 @ 12:36 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01614860
Status:
COMPLETED
Last Update Posted:
2014-09-09
First Post:
2012-06-06
Brief Title:
Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels
Status:
COMPLETED
Status Verified Date:
2014-09
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:
None
Brief Summary:
Post-discharge mortality and re-hospitalization for acute heart failure AHF affects 15 and 30 of patients respectively within 90 days With over 1 million annual hospitalizations and a financial cost exceeding 20 billion dollars AHF is a major public health burden Yet no AHF therapy to date definitively reduces morbidity and mortality and in stark contrast to heart attack patients highly rated evidence in guidelines do not exist Although AHF is a syndrome and not one disease typical treatment of patients hospitalized with AHF suggests otherwise Despite substantial differences among AHF patients therapy is largely uniform patients receive medicine to help get rid of excess volume and little else Although decades of empirical use support the symptomatic benefits of traditional therapies outcomes remain extremely poor As opposed to the one-size-fits-all approach used unsuccessfully to date in clinical trials identification of specific AHF patient sub-groups is critical so that tailored therapies can be developed and tested Preliminary data suggests that the neurohormone aldosterone may be detrimental in AHF patients Furthermore this hormone level appears to rise during hospitalization The investigators therefore propose to identify specific AHF patient phenotypes associated with high serum aldosterone levels to subsequently address the hypothesis that early aldosterone blockade continued throughout hospitalization will decrease re-hospitalization and mortality Specifically the investigators hypothesize that AHF patients with elevated serum aldosterone levels have a distinct phenotype compared to those with lower or normal aldosterone levels Specifically they will be older have a lower systolic blood pressure lower EF worse renal function higher BNP and previous hospitalization for HF
Detailed Description:
None
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 |
|---|---|---|---|
| KL2RR025740 | NIH | None | httpsreporternihgovquickSearchKL2RR025740 |