Predicting Myocardial Recovery in Heart Failure Using Cardiac Imaging
Status:
NOT_YET_RECRUITING
Trial end date:
2028-04-30
Target enrollment:
Participant gender:
Summary
Background:
Heart failure with reduced ejection fraction (HFrEF) is a heterogeneous condition with variable potential for recovery of left ventricular ejection fraction (LVEF). While improvement in LVEF and reverse remodelling of the left ventricle are linked to better prognosis and survival, the characteristics that define patients who experience recovery are less understood. An expert panel from the Journal of the American College of Cardiology emphasized the need for improved phenotyping of patients with HFrEF to clarify the natural history of LVEF recovery and support individualized management and risk stratification.
In the PRIMA-HF study, we will use perfusion imaging with \[O\]HO PET/CT as one of the methods to characterize patients with HFrEF at baseline, i.e., at the time of diagnosis. During \[O\]HO PET/CT adenosine is routinely administered at 140 g/kg/min to induce myocardial hyperemia.Patients with heart failure with reduced ejection fraction (HFrEF), however, often exhibit an attenuated response to the standard regimen, which may result in inconclusive perfusion results. Consequently, higher doses of adenosine (up to 210 g/kg/min) are occasionally required in patients with HFrEF.
Methods:
The PRIMA-HF study is a prospective cohort study investigating whether baseline imaging of myocardial structure using cardiac magnetic resonance (CMR), cardiac vascularization using coronary computed tomography, and cardiac perfusion using \[O\]HO positron emission tomography (\[O\]HO-PET) can predict LVEF recovery in patients with de novo HFrEF. The primary endpoint is the change in LVEF after 6-12 months, assessed by CMR. Patients will as well undergo a 6-minute walk test, blood volume measurements, blood sampling for analysis of inflammatory markers, and a genetic evaluation. 200 patients with new onset HFrEF will be included in the PRIMA-HF cohort.
In a subset of patients from the PRIMA-HF cohort (n=60), the randomized, double-blind Adenosine-HF substudy will be conducted. The study High Dose Adenosine During Perfusion Imaging in Heart Failure evaluates whether high-dose adenosine (210 g/kg/min) versus standard-dose (140 g/kg/min) during \[O\]HO-PET improves myocardial perfusion reserve and detection of reversible ischemia. The primary endpoint is change in myocardial blood flow.
Conclusion:
PRIMA-HF is the first prospective cohort study to comprehensively phenotype patients with newly diagnosed HFrEF using multimodality imaging and to systematically assess change in LVEF with CMR.
The randomized, double-blinded HAI-HF trial provides mechanistic insight by evaluating whether higher adenosine dosing optimizes \[O\]HO-PET perfusion imaging in HFrEF.
Together, these studies will enhance understanding of myocardial recovery potential, refine perfusion assessment strategies, and support the development of a clinically applicable prediction model to guide prognosis and therapy in patients with HFrEF.