CHFBiomarkersNCT03905252
Biomarkers for Human Heart Failure
An observational study of CHF, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to establish the various ranges of proteins that can be assayed in the plasma and urine from hospitalized patients with all classes of heart failure and/or STEMI (ST-segment elevation myocardial infarction)/NSTEMI (Non-ST-segment elevation myocardial infarction), as well as history reviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CHF
- What is being tested?
- sample analysis
- How many people
- 535 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Eight Hundred HF patients hospitalized for symptomatic HF at Mayo Clinic Hospital - St Mary's Campus, Rochester, Minnesota
Who may be able to join
- Diagnosis of Acute decompensated heart failure
Who cannot join
- Hemoglobin less than 10, active cancer, or amyloidosis Patient with dialysis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish the various ranges of proteins that can be assayed in the plasma and urine from hospitalized patients with all classes of heart failure and/or STEMI (ST-segment elevation myocardial infarction)/NSTEMI (Non-ST-segment elevation myocardial infarction), as well as history reviews.
Read the detailed description
Schematic Design of the Study: Single blood draw, one random urine and 24-hr urine collection from hospitalized patients with chronic/acute heart failure and/or STEMI-NSTEMI. If there should be a subsequent hospitalization,another collection of a 45 ml blood sample, random urine and one 24-hour urine collection may be completed if indicated at initial hospitalization.
Aims:
The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction). Follow-up hospitalizations may result in another 45 ml blood draw, random urine and 24-hr. urine collection to evaluate the outcome of the heart failure treatment used with the previous hospitalization, if indicated in consent. A history review will be necessary as well.
- Conditions
- CHF
- Being tested
- sample analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample analysisOther
blood, Random urine sample and 24-hour urine samples
What is being measured
The primary outcome is the main question the study is designed to answer.
uAGT levels in high-risk chronic HF patients
This study will provide new knowledge of the pathology and outcomes predicted by the use of uAGT in symptomatic chronic HF patients at high risk for future hospitalization and death.
Measured: 10 years
Natriuretic peptide levels in ADHF patients
new knowledge of pathology and outcomes in ADHF patients
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study startAug 2009
- Primary completionFeb 2024
- Study completionFeb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHFStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John C Burnett, Mayo Clinic
- Investigators
- John C Burnett, M.D., Principal investigator, Mayo Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905252
- Sponsor's protocol ID
- IRB # 09-003156
- Acronym
- Biomarkers
- Status last verified
- May 2024
- First submitted
- 4 Apr 2019
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Human Heart Failure
- ClinicalTrials.gov ID
- NCT03905252
- Acronym / sponsor ID
- Biomarkers / IRB # 09-003156
- Conditions
- CHF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Feb 2024 (actual)
- Study completion
- Feb 2024 (actual)
- First posted
- 5 Apr 2019 (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.
The purpose of this study is to establish the various ranges of proteins that can be assayed in the plasma and urine from hospitalized patients with all classes of heart failure and/or STEMI (ST-segment elevation myocardial infarction)/NSTEMI (Non-ST-segment elevation myocardial infarction), as well as history reviews.
Detailed description
Schematic Design of the Study: Single blood draw, one random urine and 24-hr urine collection from hospitalized patients with chronic/acute heart failure and/or STEMI-NSTEMI. If there should be a subsequent hospitalization,another collection of a 45 ml blood sample, random urine and one 24-hour urine collection may be completed if indicated at initial hospitalization.
Aims:
The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction). Follow-up hospitalizations may result in another 45 ml blood draw, random urine and 24-hr. urine collection to evaluate the outcome of the heart failure treatment used with the previous hospitalization, if indicated in consent. A history review will be necessary as well.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eight Hundred HF patients hospitalized for symptomatic HF at Mayo Clinic Hospital - St Mary's Campus, Rochester, Minnesota
Key inclusion criteria (1 listed)
- Diagnosis of Acute decompensated heart failure
Key exclusion criteria (1 listed)
- Hemoglobin less than 10, active cancer, or amyloidosis Patient with dialysis
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 |
|---|---|---|
| sample analysisblood, Random urine sample and 24-hour urine samples | Other | – |
Primary outcome
uAGT levels in high-risk chronic HF patients
Time frame: 10 years
This study will provide new knowledge of the pathology and outcomes predicted by the use of uAGT in symptomatic chronic HF patients at high risk for future hospitalization and death.
Natriuretic peptide levels in ADHF patients
Time frame: 20 years
new knowledge of pathology and outcomes in ADHF patients
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 28 May 2024.
- Individual participant dataSharing planned: No
Related trials for CHF
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Cardiovascular Diseases, Heart Diseases
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
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.
John C Burnett, M.D. principal investigator
Mayo Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHF, run by Mayo Clinic at 1 site 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 1 inclusion and 1 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
uAGT levels in high-risk chronic HF patients (time frame: 10 years). The study lists 2 primary outcomes in all. 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 28 May 2024.