Heart FailureNCT01734135
Provider Notification for High B-type Natriuretic Peptide Values
A study testing Clinical Reminder in people with Heart Failure, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
This proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging. Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Clinical Reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2015
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BNP >= 200 pg/ml in last 2 months
Who cannot join
- Measure of LVEF in the last 12 months
- Last measure of LVEF < 40%
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: Trial of Provider Notification for Patients With High B-type Natriuretic Peptide and no Imaging to Identify Unsuspected Heart Failure.
This proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging.
Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF.
Read the detailed description
Rationale: B type natriuretic peptide is known to be elevated (> 100 pg/ml) in patients with heart failure. Furthermore, treatments are available to improve survival and reduce hospitalization if the left ventricular ejection fraction (LVEF) is < 40%. Accordingly, guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work has demonstrated that patients with high BNP values do not always have a measure of left ventricular ejection.
Hypothesis: A reminder to patients with BNP and no imaging may prompt providers to order appropriate imaging potentially leading to 1) identification of unsuspected depressed ejection fraction and 2) more appropriate treatment.
- Conditions
- Heart Failure
- Being tested
- Clinical Reminder
- Keywords
- B type natriuretic peptide, heart failure, cardiac imaging, quality of care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ReminderOther
A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care |
| Clinical Reminder | Experimental | A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete. Receives: Other: Clinical Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of left ventricular ejection fraction
numerator: Measurement of left ventricular ejection fraction within 6 months of randomization.
denominator: All randomized patients
Measured: 6 months after randomization
Secondary outcomes (2)
Identification of LVEF < 40%
Numerator: number of patients identified with an LVEF< 40% Denominator: all randomized patients
Measured: 6 months following randomizaiton
Treatment of Low LVEF
Numerator: number of patients with an LVEF < 40% and treatment with either an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or evidence based beta-blocker (carvedilol, metoprolol succinate, bisoprolol).
Denominator: all randomized patients.
Measured: 6 months following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2015
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Heidenreich, VA Palo Alto Health Care System
- Investigators
- Paul A Heidenreich, MD, MS, Principal investigator, VA Palo Alto HCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734135
- Sponsor's protocol ID
- CHFQUERI-1101
- Status last verified
- Apr 2016
- First submitted
- 20 Nov 2012
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Provider Notification for Patients With High B-type Natriuretic Peptide and no Imaging to Identify Unsuspected Heart Failure.
- ClinicalTrials.gov ID
- NCT01734135
- Acronym / sponsor ID
- CHFQUERI-1101
- Conditions
- Heart Failure
- Keywords
- B type natriuretic peptide, heart failure, cardiac imaging, quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Nov 2012 (estimated)
- 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 proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging.
Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF.
Detailed description
Rationale: B type natriuretic peptide is known to be elevated (> 100 pg/ml) in patients with heart failure. Furthermore, treatments are available to improve survival and reduce hospitalization if the left ventricular ejection fraction (LVEF) is < 40%. Accordingly, guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work has demonstrated that patients with high BNP values do not always have a measure of left ventricular ejection.
Hypothesis: A reminder to patients with BNP and no imaging may prompt providers to order appropriate imaging potentially leading to 1) identification of unsuspected depressed ejection fraction and 2) more appropriate treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care |
| Clinical Reminder | Experimental | Other: Clinical ReminderA note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BNP >= 200 pg/ml in last 2 months
Key exclusion criteria (2 listed)
- Measure of LVEF in the last 12 months
- Last measure of LVEF < 40%
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 |
|---|---|---|
| Clinical ReminderA note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete. | Other | Clinical Reminder |
Primary outcome
Measurement of left ventricular ejection fraction
Time frame: 6 months after randomization
numerator: Measurement of left ventricular ejection fraction within 6 months of randomization. denominator: All randomized patients
2 secondary outcomes
Identification of LVEF < 40%
Time frame: 6 months following randomizaiton
Treatment of Low LVEF
Time frame: 6 months following randomization
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 19 Sep 2025.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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.
Paul A Heidenreich, MD, MS principal investigator
VA Palo Alto HCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Reminder in people with Heart Failure, run by VA Palo Alto Health Care 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 1 inclusion and 2 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 19 Sep 2025. 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?
Measurement of left ventricular ejection fraction (time frame: 6 months after randomization). 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 19 Sep 2025.