Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Pang, Northwestern University
ClinicalTrials.gov Identifier:
NCT01614860
First received: June 6, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition
Acute Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • There is no prespecified primary outcome as this is an exploratory study [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • There is no secondary outcome as this is an exploratory study [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To prospectively examine the baseline and dynamic phenotype of AHFS patients in relation to aldosterone levels on initial presentation. [ Time Frame: two years ] [ Designated as safety issue: No ]

    Hypothesis 2.1: The "high aldosterone" phenotypic profile identified in Aim 1 will be associated with high aldosterone levels on initial presentation to the ER in our prospective replication study.

    Hypothesis 2.2: AHFS patients with high aldosterone levels on presentation will have increased high-sensitivity troponin release and echocardiographic markers of increased myocardial and atrial fibrosis.

    Hypothesis 2.3: Repeat examination at 48 hours after initial presentation will demonstrate lack of improvement in laboratory and echocardiographic biomarkers of congestion, myocyte injury, and fibrosis in AHFS patients with high aldosterone levels, suggesting a time-sensitive component to aldosterone antagonism in AHFS.



Biospecimen Retention:   Samples Without DNA

Plasma storage for potential future studies with existing or novel biomarkers.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who present to the Emergency Department (ED) with signs and symptoms of AHF

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614860

Contacts
Contact: Peter S Pang, MD 312.694.7000 ppang@northwestern.edu
Contact: Jill Sears 312.694.7000 jes622@gmail.com

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Peter S Pang, MD    312-694-7000      
Principal Investigator: Peter S Pang, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Peter S Pang, MD Northwestern University
  More Information

No publications provided

Responsible Party: Peter Pang, Associate Professor of Emergency Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01614860     History of Changes
Other Study ID Numbers: KL2-2012NWAHF, KL2RR025740
Study First Received: June 6, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Aldosterone
Echocardiography
Neurohormones

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014