Heart Failure With Reduced Ejection FractionNCT03551756
Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
An observational study of Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, run by CirQuest Labs, LLC at 3 sites in United States.
Trial summary
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease
- What is being tested?
- Biomarker Assessment
- How many people
- 94 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Aug 2018to 3 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 subjects with the study diagnosis and 20 healthy age-matched subjects, no restrictions on gender, race, or ethnicity
Who may be able to join
- Group 1: Heart Failure with Coronary Artery Disease Subjects
- Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in last 12 months prior to enrollment.)
- Significant underlying coronary artery disease as evidenced by:
- previous myocardial infarction
- prior coronary artery bypass graft
- 50% coronary stenosis of one or more arteries and/or
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- history of percutaneous coronary intervention with or without stenting
- Age 18 years or older at the first screening visit
- Group 2: Healthy Subjects
- Age 18 years or older at the first screening visit and within 20% of mean age of Group 1 Subjects
Who cannot join
- Group 1:
- Documented history of "severe" valvular disease
- Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.
- Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
- Group 2:
- Known significant cardiovascular or hematological condition
Show all 10Show fewer
- Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
- Recent cold or flu symptoms, respiratory infection or surgery (within 2 weeks of screening)
- History of Asthma
- History of peptic ulcers
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Stern Cardiovascular
Germantown, Tennessee, 38138
University of Florida
Jacksonville, Florida, 32209
CirQuest Labs, LLC
Memphis, Tennessee, 38112
About this study
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
Read the detailed description
This is a cross-sectional, single center exploratory study of plasma biomarker levels in adults with decompensated heart failure and significant underlying coronary artery disease as compared with age-matched healthy controls. Subjects will not receive a therapeutic treatment as part of this study and will undergo a single blood draw.
- Being tested
- Biomarker Assessment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker AssessmentOther
Exploratory Biomarker Analysis for cardiac patients versus healthy adults
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure & Coronary Artery Disease | Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease Receives: Other: Biomarker Assessment | |
| Healthy Adult | Biomarker assessment in 20 healthy age-matched subjects Receives: Other: Biomarker Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker assessment
Exploratory biomarker analysis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start13 Aug 2018
- Primary completion30 Oct 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- CirQuest Labs, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Lisa K. Jennings, PhD, Principal investigator, CirQuest Labs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551756
- Sponsor's protocol ID
- CQ 17-11-009
- Status last verified
- Jan 2020
- First submitted
- 29 May 2018
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03551756
- Acronym / sponsor ID
- CQ 17-11-009
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- CirQuest Labs, LLCUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
Detailed description
This is a cross-sectional, single center exploratory study of plasma biomarker levels in adults with decompensated heart failure and significant underlying coronary artery disease as compared with age-matched healthy controls. Subjects will not receive a therapeutic treatment as part of this study and will undergo a single blood draw.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure & Coronary Artery Disease | – | Other: Biomarker AssessmentBiomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease |
| Healthy Adult | – | Other: Biomarker AssessmentBiomarker assessment in 20 healthy age-matched subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 subjects with the study diagnosis and 20 healthy age-matched subjects, no restrictions on gender, race, or ethnicity
Key inclusion criteria (10 listed)
- Group 1: Heart Failure with Coronary Artery Disease Subjects
- Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in last 12 months prior to enrollment.)
- Significant underlying coronary artery disease as evidenced by:
- previous myocardial infarction
- prior coronary artery bypass graft
Key exclusion criteria (10 listed)
- Documented history of "severe" valvular disease
- Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.
- Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
- Known significant cardiovascular or hematological condition
- Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker AssessmentExploratory Biomarker Analysis for cardiac patients versus healthy adults | Other | Healthy Adult, Heart Failure & Coronary Artery Disease |
Primary outcome
Biomarker assessment
Time frame: 1 day
Exploratory biomarker analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa K. Jennings, PhD principal investigator
CirQuest Labs, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, run by CirQuest Labs, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker assessment (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.