Heart FailureNCT05170165
A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF
An observational study of Heart Failure, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Using a clinical decision software to provide specific recommendation of a medication at a certain dosage
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 25 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients >18 years with HFrEF who have suboptimal HF medical regimen
Who may be able to join
- Diagnosis of HFrEF (left ejection fraction < 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
- New York Heart Association (NYHA) class II-III at most recent screening assessment.
- GDMT composite score of less than or equal to 50% at baseline
Who cannot join
- Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
- Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m2.
- Baseline systolic blood pressure < 100 mmHg.
- Concomitant use of ACE, ARB, and/or ARNI
- Polycystic kidney disease
- History of angioedema
Show all 15Show fewer
- History of or currently on a transplant list
- Left ventricular assist device
- Uncontrolled asthma
- Severe COPD
- Cirrhosis
- Currently receiving hospice or comfort care
- Patient not proficient with written and spoken English
- Patient has diminished decision making capability
- History of non-compliance
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Maurice Herring, 310-248-8375, maurice.herring@cshs.org
About this study
Official title: A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF
The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).
Read the detailed description
The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.
- Conditions
- Heart Failure
- Being tested
- Using a clinical decision software to provide specific recommendation of a medication at a certain dosage
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a clinical decision software to provide specific recommendation of a medication at a certain dosageOther
During routine follow-up, clinicians, cardiologists, and NPs who have a scheduled visit with an enrolled patient will be offered a medication recommendation. The medication recommendation will be generated by the clinical decision support tool. The software will advise the cardiologist whether an HF medication should be initiated, discontinued, or the dosage titrated and if the patient requires labs. In addition, the software, or decision engine (DE), will be run once weekly and every time the patient has new basic metabolic panel results. If the patient is admitted to the hospital, skilled nursing facility, or inpatient rehabilitation unit, the use of DE will be placed on hold until the patient is discharged and at home.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Subjects | Test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF). Receives: Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients at or above 50% target dose of GDMT in HFrEF patients
Change in the proportion of patients at or above 50% target dose of GDMT in
Measured: 6 months
Secondary outcomes (1)
Percentage of accepted medication recommendations
The percentage of DE output medication recommendations in which the clinician accepts alerts
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start12 Jan 2022
- Primary completion25 Sep 2023 (estimated)
- Study completion25 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Khandwalla, Cedars-Sinai Medical Center
- Investigators
- Raj Khandwalla, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170165
- Sponsor's protocol ID
- HFDTx study 1618
- Status last verified
- Aug 2023
- First submitted
- 22 Dec 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data that underlie the results after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF
- ClinicalTrials.gov ID
- NCT05170165
- Acronym / sponsor ID
- HFDTx study 1618
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 25 Sep 2023 (estimated)
- Study completion
- 25 Sep 2023 (estimated)
- First posted
- 27 Dec 2021 (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 test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).
Detailed description
The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects | – | Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosageTest a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years with HFrEF who have suboptimal HF medical regimen
Key inclusion criteria (3 listed)
- Diagnosis of HFrEF (left ejection fraction < 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
- New York Heart Association (NYHA) class II-III at most recent screening assessment.
- GDMT composite score of less than or equal to 50% at baseline
Key exclusion criteria (15 listed)
- Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
- Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m2.
- Baseline systolic blood pressure < 100 mmHg.
- Concomitant use of ACE, ARB, and/or ARNI
- Polycystic kidney disease
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 |
|---|---|---|
| Using a clinical decision software to provide specific recommendation of a medication at a certain dosageDuring routine follow-up, clinicians, cardiologists, and NPs who have a scheduled visit with an enrolled patient will be offered a medication recommendation. The medication recommendation will be generated by the clinical decision support tool. The software will advise the cardiologist whether an HF medication should be initiated, discontinued, or the dosage titrated and if the patient requires labs. In addition, the software, or decision engine (DE), will be run once weekly and every time the patient has new basic metabolic panel results. If the patient is admitted to the hospital, skilled nursing facility, or inpatient rehabilitation unit, the use of DE will be placed on hold until the patient is discharged and at home. | Other | Enrolled Subjects |
Primary outcome
Proportion of patients at or above 50% target dose of GDMT in HFrEF patients
Time frame: 6 months
Change in the proportion of patients at or above 50% target dose of GDMT in
1 secondary outcome
Percentage of accepted medication recommendations
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Yes. All of the individual participant data that underlie the results after deidentification.
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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.
Raj Khandwalla, MD principal investigator
Cedars-Sinai Medical Center
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 Heart Failure, run by Cedars-Sinai Medical Center 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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 5 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allison Peterson, PhD (424-314-0048, allison.peterson@csmns.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients at or above 50% target dose of GDMT in HFrEF patients (time frame: 6 months). 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 5 Sep 2023.