Congestive Heart FailureNCT05251974
Assay to Measure Beta Blocker Adherence
An observational study of Congestive Heart Failure and Medication Adherence, run by Summa Health System at 1 site in United States.
Trial summary
This study will assess the feasibility and efficacy of using serum assay developed by Quest Diagnostics to detect the presence of beta blockers, specifically carvedilol and metoprolol succinate, in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Congestive Heart Failure, Medication Adherence
- What is being tested?
- Quest beta blocker assay
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2022to 15 Nov 2023
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized with a primary diagnosis of heart failure with reduced ejection fraction at Summa Health - Akron Campus.
Who may be able to join
- Age 18-89
- Admitted for primary diagnosis of heart failure with reduced ejection fraction
- Prescribed carvedilol or metoprolol succinate for beta blocker therapy
- Will be following up at 95 Arch St. Clinic
Who cannot join
- Under age 18/over age 89
- Patients that plan to follow up somewhere other than the 95 Arch St. Clinic
- Patients with prior heart transplant or a left ventricular assist device
- Patient is unable to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Medication Compliance, Verified With Medication Level Testing, on Unplanned Hospital Readmission or Urgent Outpatient Visit in Patients With Acute Decompensated Heart Failure
This study will assess the feasibility and efficacy of using serum assay developed by Quest Diagnostics to detect the presence of beta blockers, specifically carvedilol and metoprolol succinate, in patients with heart failure.
Read the detailed description
Patients admitted to the Summa Akron City campus with a primary diagnosis of heart failure will be invited to participate 1 to 2 days prior to expected discharge. A research nurse with the Summa CRC will enroll patients, obtain informed consent, and perform all study-related blood sample collection. We will collect blood from each enrolled patient up to three times. The first blood sample collection will be obtained just prior to discharge. A second and third blood sample will be collected at the patient's routine 7-day and 30-day post-hospital follow up appointment, respectively. Each blood draw will collect 13mL of blood from each patient, for a total of up to 39mL of blood for the entire study. If the patient is readmitted for heart failure prior to the 7- or 30-day follow up appointment, the subsequent blood draws will be cancelled.
Our enrollment target is 100 patients. Patients admitted to the Summa Akron City campus with a primary diagnosis of heart failure will be invited to participate 1 to 2 days prior to expected discharge. A research nurse with the Summa CRC will enroll patients, obtain informed consent, and perform all study-related blood sample collection. We will collect blood from each enrolled patient up to three times. The first blood sample collection will be obtained just prior to discharge. A second and third blood sample will be collected at the patient's routine 7-day and 30-day post-hospital follow up appointment, respectively. Each blood draw will collect 13mL of blood from each patient, for a total of up to 39mL of blood for the entire study. If the patient is readmitted for heart failure prior to the 7- or 30-day follow up appointment, the subsequent blood draws will be cancelled.
Additionally, study personnel will asses medication adherence at the 7- and 30-day follow up appointments by asking the patient 1) if they took their most recent scheduled dose of their beta blocker, and 2) how often do they miss their scheduled beta blocker dose. Study personnel will also verify medication list and record other cardiology medications used at the 7- and 30-day follow ups. Blood samples will be labeled with the study code and patient DOB, and sent to Quest Diagnostics via courier for analysis. Date/time for each blood sample will be recorded. This information will be recorded on the Quest Visit Worksheet which will be stored in the subjects study binder. For each blood sample, Quest will quantify the amount of beta blocker present, as well as creatinine, and NT-proBNP level present. The patient's providers will be blinded to the assay results until after the 30-day study period has elapsed.
- Conditions
- Congestive Heart Failure, Medication Adherence
- Being tested
- Quest beta blocker assay
- Medical subject headings
- Heart Failure, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quest beta blocker assayDiagnostic test
Blood assay to detect presence of beta blocker medications
| Study group | Role | What they receive |
|---|---|---|
| Compliant with beta blocker therapy | Patients observed to be compliant with beta blocker therapy by blood assay Receives: Diagnostic Test: Quest beta blocker assay | |
| Non-compliant with beta blocker therapy | Patients observed to be non-compliant with beta blocker therapy by blood assay Receives: Diagnostic Test: Quest beta blocker assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission/urgent outpatient visit
Requiring readmission or an urgent outpatient visit for heart failure
Measured: 30 days
Secondary outcomes (1)
Mortality
All-cause mortality during the study period
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start2 Mar 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Why it stopped: Quest Diagnostics terminated study early - did not want to continue to support single-site study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute
- Responsible party
- Sponsor
- Investigators
- Kenneth Varian, MD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251974
- Sponsor's protocol ID
- 21145
- Status last verified
- Nov 2023
- First submitted
- 11 Feb 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A - no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medication Compliance, Verified With Medication Level Testing, on Unplanned Hospital Readmission or Urgent Outpatient Visit in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT05251974
- Acronym / sponsor ID
- 21145
- Conditions
- Congestive Heart Failure, Medication Adherence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Quest Diagnostics terminated study early - did not want to continue to support single-site study
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 23 Feb 2022 (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.
This study will assess the feasibility and efficacy of using serum assay developed by Quest Diagnostics to detect the presence of beta blockers, specifically carvedilol and metoprolol succinate, in patients with heart failure.
Detailed description
Patients admitted to the Summa Akron City campus with a primary diagnosis of heart failure will be invited to participate 1 to 2 days prior to expected discharge. A research nurse with the Summa CRC will enroll patients, obtain informed consent, and perform all study-related blood sample collection. We will collect blood from each enrolled patient up to three times. The first blood sample collection will be obtained just prior to discharge. A second and third blood sample will be collected at the patient's routine 7-day and 30-day post-hospital follow up appointment, respectively. Each blood draw will collect 13mL of blood from each patient, for a total of up to 39mL of blood for the entire study. If the patient is readmitted for heart failure prior to the 7- or 30-day follow up appointment, the subsequent blood draws will be cancelled.
Our enrollment target is 100 patients. Patients admitted to the Summa Akron City campus with a primary diagnosis of heart failure will be invited to participate 1 to 2 days prior to expected discharge. A research nurse with the Summa CRC will enroll patients, obtain informed consent, and perform all study-related blood sample collection. We will collect blood from each enrolled patient up to three times. The first blood sample collection will be obtained just prior to discharge. A second and third blood sample will be collected at the patient's routine 7-day and 30-day post-hospital follow up appointment, respectively. Each blood draw will collect 13mL of blood from each patient, for a total of up to 39mL of blood for the entire study. If the patient is readmitted for heart failure prior to the 7- or 30-day follow up appointment, the subsequent blood draws will be cancelled.
Additionally, study personnel will asses medication adherence at the 7- and 30-day follow up appointments by asking the patient 1) if they took their most recent scheduled dose of their beta blocker, and 2) how often do they miss their scheduled beta blocker dose. Study personnel will also verify medication list and record other cardiology medications used at the 7- and 30-day follow ups. Blood samples will be labeled with the study code and patient DOB, and sent to Quest Diagnostics via courier for analysis. Date/time for each blood sample will be recorded. This information will be recorded on the Quest Visit Worksheet which will be stored in the subjects study binder. For each blood sample, Quest will quantify the amount of beta blocker present, as well as creatinine, and NT-proBNP level present. The patient's providers will be blinded to the assay results until after the 30-day study period has elapsed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliant with beta blocker therapy | – | Diagnostic Test: Quest beta blocker assayPatients observed to be compliant with beta blocker therapy by blood assay |
| Non-compliant with beta blocker therapy | – | Diagnostic Test: Quest beta blocker assayPatients observed to be non-compliant with beta blocker therapy by blood assay |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized with a primary diagnosis of heart failure with reduced ejection fraction at Summa Health - Akron Campus.
Key inclusion criteria (4 listed)
- Age 18-89
- Admitted for primary diagnosis of heart failure with reduced ejection fraction
- Prescribed carvedilol or metoprolol succinate for beta blocker therapy
- Will be following up at 95 Arch St. Clinic
Key exclusion criteria (4 listed)
- Under age 18/over age 89
- Patients that plan to follow up somewhere other than the 95 Arch St. Clinic
- Patients with prior heart transplant or a left ventricular assist device
- Patient is unable to provide consent.
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 |
|---|---|---|
| Quest beta blocker assayBlood assay to detect presence of beta blocker medications | Diagnostic test | Compliant with beta blocker therapy, Non-compliant with beta blocker therapy |
Primary outcome
Readmission/urgent outpatient visit
Time frame: 30 days
Requiring readmission or an urgent outpatient visit for heart failure
1 secondary outcome
Mortality
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Quest Diagnostics terminated study early - did not want to continue to support single-site study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. N/A - no plan to make IPD available.
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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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.
Kenneth Varian, MD principal investigator
Summa Health System
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 Congestive Heart Failure and Medication Adherence, run by Summa Health System 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Nov 2023. 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 was stopped early (reason given: Quest Diagnostics terminated study early - did not want to continue to support single-site study). Results are not available in the source record.
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?
Readmission/urgent outpatient visit (time frame: 30 days). 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 22 Nov 2023.