An interventional study of Notification and Cardiology Referral and Notification and Cardiology Referral Plus Care Navigation in Heart Failure, sponsored by Palo Alto Veterans Institute for Research. Not yet recruiting. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Palo Alto Veterans Institute for Research · Not applicable, Interventional, and Prevention
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:
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 250 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Palo Alto Veterans Institute for Research is the lead sponsor of 53 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives usual care without any intervention.
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.
Other: Notification and Cardiology Referral
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.
Other: Notification and Cardiology Referral Plus Care Navigation
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.
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.
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
Time frame: 6 months
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
Time frame: 6 months
Refill rates
Proportion of new preventive medications prescribed that were refilled after the first prescription
Time frame: 6 months
Blood pressure measurement
Blood pressure recorded in the health record during the 6-month follow up period (yes/no)
Time frame: 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)
Time frame: 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
Time frame: 6 months
Cardiology referrals
Proportion of patients enrolled in the intervention arms with a signed cardiology referral
Time frame: 6 months
Cardiology visits
Proportion of patients in the intervention arms with signed cardiology referrals who complete at least one cardiology visit
Time frame: 6 months
Care navigation opt-outs
Proportion of patients in the care navigation arm opting out of care navigation contact
Time frame: 6 months
Care navigator contact frequency
Frequency of contacts by the care navigator with patients, average number of contacts per patient
Time frame: 6 months
LDL cholesterol tested
LDL cholesterol tested (yes/no)
Time frame: 6 months
Hemoglobin A1c tested
Hemoglobin A1c tested (yes/no)
Time frame: 6 months
BMI recorded
BMI recorded (yes/no)
Time frame: 6 months
Change in LDL cholesterol
Average change in LDL cholesterol from baseline to 6 months (most recent measurement carried forward at 6 months)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Care navigator contact type
Proportion of contacts by the care navigator with patients by phone, messaging, and other means
Time frame: 6 months
Care navigator contact duration
Average cumulative duration of contacts by the care navigator per patient
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No — VHA prohibits most data sharing.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Palo Alto Veterans Institute for Research