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NCT01614860 · ClinicalTrials.gov registry record

Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels

A clinical trial, sponsored by Northwestern University.

Completed
Registry status
90
Enrollment target

NCT01614860: Completed study, sponsored by Northwestern University.

NCT01614860 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01614860 has completed, sponsored by Northwestern University.

COMPLETED
Registry status
90 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2012-05
Est. Completion 2014-06
Northwestern University

1,209 total trials

What the finished NCT01614860 record still lists

NCT01614860 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01614860 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01614860 about?

NCT01614860 is a clinical study titled "Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels". 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 d...

What is the current status of trial NCT01614860?

This trial is currently completed. The enrollment target is 90 participants. The study started on 2012-05. Estimated completion is 2014-06.

Who is sponsoring clinical trial NCT01614860?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01614860, the US trial registry maintained by the National Library of Medicine. NCT01614860 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.