Heart Failure Clinical Trial

Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Male or female ≥ 18 years of age
AHF is the primary working diagnosis for ER management and treatment Have received or will receive IV diuretic therapy
Enrolled within 12 hours of initial diuretic dose order

Exclusion criteria:

Serum Cr ≥ 2.5mg/dL (males) or 2.0mg/dL (females), or eGFR < 20 ml/min/1.73m2
Serum potassium ≥ 5.5 mEq/L
Transplant recipients of any kind
Fever > 101.0
Severe lung disease (required home O2 or daily oral steroids)
Acute coronary syndrome within last 30 days
Major surgery within last 30 days
Known hypertrophic obstructive cardiomyopathy, pericardial constriction, or hemodynamically significant valvular disease
Life expectancy less than 12 months for any reason
Current treatment for any malignancy of any kind
Cardiogenic shock and/or requiring IV inotropic therapy
Pregnant or recently pregnant within last 90 days
Known intolerance to aldosterone antagonist
Inability to give appropriate written consent

Study is for people with:

Heart Failure

Estimated Enrollment:

90

Study ID:

NCT01614860

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There is 1 Location for this study

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Northwestern Memorial Hospital
Chicago Illinois, 60611, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

90

Study ID:

NCT01614860

Recruitment Status:

Completed

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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