HFpEF Trial Recruitment Assistant
A practical guide for CABANA-HF site teams on finding, screening, and enrolling patients who have both atrial fibrillation and HFpEF.
A practical guide for CABANA-HF site teams on finding, screening, and enrolling patients who have both atrial fibrillation and HFpEF.
HFpEF accounts for roughly half of all heart failure and affects about 1% of the U.S. population — over 3 million people. Despite that prevalence, HFpEF trials consistently struggle to enroll. The patients exist; they are simply hard to find, because HFpEF is under-diagnosed and the people who care for these patients are spread across many specialties.
CABANA-HF enrolls 1,552 patients across approximately 120 sites — roughly 0.5–1 patient per site per month. Unlike a pure HFpEF trial, every CABANA-HF participant must have both documented atrial fibrillation and HFpEF. That makes the electrophysiology and heart failure clinics equally important sources, and it is why each site is led by an EP and an HF co-PI.
The H2FPEF score calculator, with guidance on how to read it against CABANA-HF's own eligibility criteria.
Where the patients actually are — the wards, the echo lab, the cath lab, the PH clinic, and the AF clinic.
Diagnostic pitfalls, common misconceptions, HFpEF masqueraders, and what the highest-enrolling sites do differently.
The H2FPEF score helps separate HFpEF from non-cardiac causes of dyspnea. Tick what applies to your patient; the score updates as you go.
Low probability
Probability of HFpEF below 20%.
HFpEF unlikely on these criteria alone.
The H2FPEF score was derived and validated in patients with an LVEF ≥ 50%, while CABANA-HF enrolls at LVEF > 40% — so treat it as a guide to the likelihood of HFpEF, not as an eligibility test. Note too that atrial fibrillation alone contributes 3 of the 9 points, and every CABANA-HF candidate has AF by definition; a high score in this population is therefore less discriminating than it looks. Always confirm against the full inclusion and exclusion criteria.
Notes on scoring:
Waiting for referrals will not fill a HFpEF trial. These are the places where the patients are already sitting in your health system.
Searching on a discharge diagnosis of heart failure will miss many HFpEF patients, because the diagnosis is so often not made. Look for the fingerprints of treatment instead.
Visit the patient in hospital, before discharge, even if they are not yet eligible. That personal contact does more for later enrollment than any letter or phone call.
The echo lab is the single highest-yield screening source for HFpEF, because almost every candidate passes through it.
Invasive hemodynamics settle the diagnosis that echo can only suggest, and CABANA-HF accepts a resting PCWP ≥ 15 mmHg as a qualifying risk-enhancing feature.
83% of patients with HFpEF have an elevated PA systolic pressure on echo, PASP is among the best single echo parameters for the diagnosis, and HFpEF is the number one cause of an elevated PASP. A PH clinic is, in effect, a partly pre-screened HFpEF population.
Strange and colleagues (Heart, 2012), studying an Australian community of 165,450 people, found HFpEF to be the leading cause of an elevated PA systolic pressure on echocardiography.
This hot spot is specific to CABANA-HF. Every participant needs documented AF and eligibility for catheter ablation, so the AF and EP clinics are the other half of your screening effort — and the half a conventional HFpEF trial would not use.
Your EP and HF co-PIs are screening two different populations for the same patient. Agree early who screens which list, and meet regularly so candidates found in one clinic are not lost in the handover to the other.
Build a standing registry of candidates rather than starting the search fresh each month. Sites that enroll well treat recruitment as a continuous process, not a campaign.
Internists, geriatricians, and pulmonologists send you these patients. Make sure they know about the morbidity and mortality of HFpEF, the high rate of heart failure hospitalization and re-hospitalization, how few proven treatments exist, and that CABANA-HF is open.
Recruitment improves when the whole team recognizes HFpEF, knows what it is not, and understands why the diagnosis is so often missed.
Many clinicians still believe there is little to offer beyond diuretics, so they do not refer. That belief is the single largest cultural barrier to enrollment — and addressing it directly with your referrers is part of recruitment.
These conditions can look like HFpEF and should be excluded before enrolling. Several are also explicit CABANA-HF exclusions.
A patient whose breathlessness is mostly explained by something else — COPD is the usual example — should not be enrolled. They are unlikely to benefit, and they dilute the trial's ability to answer its question.
The greatest risk to CABANA-HF is not slow enrollment but crossover to ablation outside the protocol. Frame the trial honestly from the first conversation: whether ablation improves outcomes in HFpEF is genuinely unknown, which is exactly why the trial is being done.
This page is an educational aid for CABANA-HF site teams. It is not a substitute for clinical judgment, and it does not replace the protocol. The screening tools here are drawn from published research and expert recommendation; eligibility for CABANA-HF is determined solely by the protocol inclusion and exclusion criteria, confirmed by the site investigator.
The coordinating center can help your site build a screening process that fits your institution.
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