Heart FailureNOVA-HFNCT07910084
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
A study testing Notification and Cardiology Referral and Notification and Cardiology Referral Plus Care Navigation in people with Heart Failure, run by Palo Alto Veterans Institute for Research.
Trial summary
The purpose of this study is to learn whether connecting people at high risk for developing heart failure to a heart doctor (cardiologist) leads to greater use of treatments that can lower that risk. Heart failure is a condition in which the heart cannot pump blood as well as it should. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Notification and Cardiology Referral and Notification and Cardiology Referral Plus Care Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-79 years
- Receive primary care at Veterans Affairs (VA) medical centers in the VA region including Northern and Central California, Nevada, Hawaii, and the Pacific Islands with at least 1 primary care visit in the prior 2 years
- Live in a rural location defined using established VA definitions of Rural-Urban Commuting Area (RUCA) codes >1.1 - <10.0 for "rural" and RUCA code 10.0 for "highly rural"
- Estimated 10-year risk of developing heart failure using the American Heart Association's PREVENT-HF equation ≥10%
- Presence of at least 3 opportunities to improve preventive care identified using electronic health records data from a prespecified opportunity list
Who cannot join
- Documented diagnosis of heart failure or atherosclerotic cardiovascular disease in the prior 2 years
- Documented diagnosis of a severe illness, including end-stage kidney disease, severe liver disease, metastatic cancer, or dementia, in the prior 2 years
- Visit with a VA cardiologist in the prior 2 years
- Insufficient data to calculate the PREVENT-HF 10-year risk from the prior 2 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Neil M Kalwani, MD, MPP contact
About this study
The purpose of this study is to learn whether connecting people at high risk for developing heart failure to a heart doctor (cardiologist) leads to greater use of treatments that can lower that risk. Heart failure is a condition in which the heart cannot pump blood as well as it should. The study focuses on Veterans living in rural areas, who often have a higher risk of heart failure and less access to heart care.
The study team will use health record information to find Veterans who are at high risk for heart failure but do not yet have it, and who have health factors that could be improved with preventive treatment. The study team expects that telling these Veterans and their primary care providers about the elevated risk, and offering early cardiology care, will lead to greater use of treatments known to help prevent heart failure compared with usual care.
Read more
The main questions the study aims to answer are:
- Does informing a Veteran and their primary care provider about the Veteran's elevated risk for heart failure, and offering a referral to a cardiologist, increase the use of treatments known to help prevent heart failure?
- Does having a care navigator reach out to Veterans and their primary care providers further help connect these Veterans to preventive care?
Veterans in the study will be placed by chance into one of three groups. One group will receive usual care. A second group, along with their primary care provider, will be told about the Veteran's elevated risk for heart failure and offered a referral to a cardiologist. A third group will receive that same information and referral offer, plus outreach from a care navigator who can explain more about heart failure and the reason for the referral, answer questions, and help with scheduling.
- Conditions
- Heart Failure
- Being tested
- Notification and Cardiology Referral, Notification and Cardiology Referral Plus Care Navigation
- Keywords
- Heart Failure, Rural, Veterans
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Notification and Cardiology ReferralOther
Patient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign.
Notification and Cardiology Referral Plus Care NavigationOther
Patient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign. In addition, a care navigator proactively reaches out to the patient to explain the trial, provide education on heart failure risk, and assist with cardiology referral coordination.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Receives usual care without any intervention. |
| Notification and Cardiology Referral | Experimental | Patient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign. Receives: Other: Notification and Cardiology Referral |
| Notification and Cardiology Referral Plus Care Navigation | Experimental | Patient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign. In addition, a care navigator proactively reaches out to the patient to explain the trial, provide education on heart failure risk, and assist with cardiology referral coordination. Receives: Other: Notification and Cardiology Referral Plus Care Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
New preventive treatments
Number of preventive treatments initiated or intensified to address prespecified opportunities to reduce heart failure risk in the 6 months after trial enrollment
Measured: 6 months
Secondary outcomes (19)
Primary outcome by clinician type
Number of preventive treatments initiated or intensified to address prespecified opportunities to reduce heart failure risk in the 6 months after trial enrollment by primary care versus cardiology providers
Measured: 6 months
Refill rates
Proportion of new preventive medications prescribed that were refilled after the first prescription
Measured: 6 months
Blood pressure measurement
Blood pressure recorded in the health record during the 6-month follow up period (yes/no)
Measured: 6 months
Change in systolic and diastolic blood pressure if elevated at baseline
Average change in systolic and diastolic blood pressure among those with elevated blood pressure (>130 mmHg systolic, >80 mmHg diastolic) at baseline from baseline value to 6 months (most recent measurement carried forward at 6 months)
Measured: 6 months
New heart failure or reduced left ventricular ejection fraction
New diagnoses of heart failure (defined as the presence of 2 ICD-10 codes for heart failure at outpatient or acute care visits) or newly reduced left ventricular ejection fraction (LVEF) <50% on echocardiography
Measured: 6 months
Cardiology referrals
Proportion of patients enrolled in the intervention arms with a signed cardiology referral
Measured: 6 months
Cardiology visits
Proportion of patients in the intervention arms with signed cardiology referrals who complete at least one cardiology visit
Measured: 6 months
Care navigation opt-outs
Proportion of patients in the care navigation arm opting out of care navigation contact
Measured: 6 months
Care navigator contact frequency
Frequency of contacts by the care navigator with patients, average number of contacts per patient
Measured: 6 months
LDL cholesterol tested
LDL cholesterol tested (yes/no)
Measured: 6 months
Hemoglobin A1c tested
Hemoglobin A1c tested (yes/no)
Measured: 6 months
BMI recorded
BMI recorded (yes/no)
Measured: 6 months
Change in LDL cholesterol
Average change in LDL cholesterol from baseline to 6 months (most recent measurement carried forward at 6 months)
Measured: 6 months
Change in hemoglobin A1c, if elevated at baseline
Average change in hemoglobin A1c among those with elevated hemoglobin A1c (>5.6) from baseline to 6 months (most recent measurement carried forward at 6 months)
Measured: 6 months
Change in BMI, if elevated at baseline
Average change in BMI among those with elevated at baseline (>27) from baseline to 6 months (most recent measurement carried forward at 6 months)
Measured: 6 months
% weight loss if BMI elevated at baseline
Average % change in weight among those with BMI elevated at baseline (>27) from baseline to 6 months (most recent measurement carried forward at 6 months)
Measured: 6 months
Change in weight if BMI elevated at baseline
Average change in weight among those with BMI elevated at baseline (>27) from baseline to 6 months (most recent measurement carried forward at 6 months)
Measured: 6 months
Care navigator contact type
Proportion of contacts by the care navigator with patients by phone, messaging, and other means
Measured: 6 months
Care navigator contact duration
Average cumulative duration of contacts by the care navigator per patient
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 posted2 Nov 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Rebecca L Tisdale, MD, MPA, Principal investigator, VA Palo Alto Health Care SystemNeil M Kalwani, MD, MPP, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910084
- Sponsor's protocol ID
- HEI0048APT
- Acronym
- NOVA-HF
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: VHA prohibits most data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Notification Of High-Risk Veterans for Access to Heart Failure Prevention
- ClinicalTrials.gov ID
- NCT07910084
- Acronym / sponsor ID
- NOVA-HF / HEI0048APT
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Rural, Veterans
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Nov 2026 (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 learn whether connecting people at high risk for developing heart failure to a heart doctor (cardiologist) leads to greater use of treatments that can lower that risk. Heart failure is a condition in which the heart cannot pump blood as well as it should. The study focuses on Veterans living in rural areas, who often have a higher risk of heart failure and less access to heart care.
The study team will use health record information to find Veterans who are at high risk for heart failure but do not yet have it, and who have health factors that could be improved with preventive treatment. The study team expects that telling these Veterans and their primary care providers about the elevated risk, and offering early cardiology care, will lead to greater use of treatments known to help prevent heart failure compared with usual care.
The main questions the study aims to answer are:
- Does informing a Veteran and their primary care provider about the Veteran's elevated risk for heart failure, and offering a referral to a cardiologist, increase the use of treatments known to help prevent heart failure?
- Does having a care navigator reach out to Veterans and their primary care providers further help connect these Veterans to preventive care?
Veterans in the study will be placed by chance into one of three groups. One group will receive usual care. A second group, along with their primary care provider, will be told about the Veteran's elevated risk for heart failure and offered a referral to a cardiologist. A third group will receive that same information and referral offer, plus outreach from a care navigator who can explain more about heart failure and the reason for the referral, answer questions, and help with scheduling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Receives usual care without any intervention. |
| Notification and Cardiology Referral | Experimental | Other: Notification and Cardiology ReferralPatient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign. |
| Notification and Cardiology Referral Plus Care Navigation | Experimental | Other: Notification and Cardiology Referral Plus Care NavigationPatient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign. In addition, a care navigator proactively reaches out to the patient to explain the trial, provide education on heart failure risk, and assist with cardiology referral coordination. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-79 years
- Receive primary care at Veterans Affairs (VA) medical centers in the VA region including Northern and Central California, Nevada, Hawaii, and the Pacific Islands with at least 1 primary care visit in the prior 2 years
- Live in a rural location defined using established VA definitions of Rural-Urban Commuting Area (RUCA) codes >1.1 - <10.0 for "rural" and RUCA code 10.0 for "highly rural"
- Estimated 10-year risk of developing heart failure using the American Heart Association's PREVENT-HF equation ≥10%
- Presence of at least 3 opportunities to improve preventive care identified using electronic health records data from a prespecified opportunity list
Key exclusion criteria (4 listed)
- Documented diagnosis of heart failure or atherosclerotic cardiovascular disease in the prior 2 years
- Documented diagnosis of a severe illness, including end-stage kidney disease, severe liver disease, metastatic cancer, or dementia, in the prior 2 years
- Visit with a VA cardiologist in the prior 2 years
- Insufficient data to calculate the PREVENT-HF 10-year risk from the prior 2 years
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 |
|---|---|---|
| Notification and Cardiology ReferralPatient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign. | Other | Notification and Cardiology Referral |
| Notification and Cardiology Referral Plus Care NavigationPatient and primary care doctor receive notification of the patient's elevated heart failure risk and recommendation for cardiology referral. A cardiology referral order is pended in the electronic health record for the primary care doctor to review and sign. In addition, a care navigator proactively reaches out to the patient to explain the trial, provide education on heart failure risk, and assist with cardiology referral coordination. | Other | Notification and Cardiology Referral Plus Care Navigation |
Primary outcome
New preventive treatments
Time frame: 6 months
Number of preventive treatments initiated or intensified to address prespecified opportunities to reduce heart failure risk in the 6 months after trial enrollment
19 secondary outcomes
Primary outcome by clinician type
Time frame: 6 months
Refill rates
Time frame: 6 months
Blood pressure measurement
Time frame: 6 months
Change in systolic and diastolic blood pressure if elevated at baseline
Time frame: 6 months
New heart failure or reduced left ventricular ejection fraction
Time frame: 6 months
Cardiology referrals
Time frame: 6 months
Cardiology visits
Time frame: 6 months
Care navigation opt-outs
Time frame: 6 months
Care navigator contact frequency
Time frame: 6 months
LDL cholesterol tested
Time frame: 6 months
Hemoglobin A1c tested
Time frame: 6 months
BMI recorded
Time frame: 6 months
Change in LDL cholesterol
Time frame: 6 months
Change in hemoglobin A1c, if elevated at baseline
Time frame: 6 months
Change in BMI, if elevated at baseline
Time frame: 6 months
% weight loss if BMI elevated at baseline
Time frame: 6 months
Change in weight if BMI elevated at baseline
Time frame: 6 months
Care navigator contact type
Time frame: 6 months
Care navigator contact duration
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. VHA prohibits most data sharing.
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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.
Neil M Kalwani, MD, MPP contact
Rebecca L Tisdale, MD, MPA principal investigator
VA Palo Alto Health Care System
Neil M Kalwani, MD, MPP principal investigator
VA Palo Alto Health Care System
Questions about this trial
What is this clinical trial studying?
A study testing Notification and Cardiology Referral and Notification and Cardiology Referral Plus Care Navigation in people with Heart Failure, run by Palo Alto Veterans Institute for Research.
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 5 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca L Tisdale, MD, MPA (650-614-9997 ext. 27325, rebecca.tisdale2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New preventive treatments (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 2 Nov 2026.