Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2014 |
Start Date: | May 2012 |
End Date: | May 2014 |
Contact: | Peter S Pang, MD |
Email: | ppang@northwestern.edu |
Phone: | 312.694.7000 |
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.
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.
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
We found this trial at
1
site
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
Click here to add this to my saved trials