Identification of Patient Phenotypes Associated With Elevated Aldosterone Levels

September 7, 2014 updated by: Peter Pang, Northwestern University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
There is no prespecified primary outcome as this is an exploratory study
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
There is no secondary outcome as this is an exploratory study
Time Frame: 2 years
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To prospectively examine the baseline and dynamic phenotype of AHFS patients in relation to aldosterone levels on initial presentation.
Time Frame: two years

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.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Research Resources (NCRR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter S Pang, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KL2-2012NWAHF
  • KL2RR025740 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings