Heart Failure Clinical Trials - Broadening the Definition of the Ideal Heart Failure Site Investigator

Abstract

Introduction Despite a fiercely competitive clinical trial environment in heart failure (HF) and persistently low recruitment rates, industry and government sponsors continue to primarily engage cardiologists as U.S. site investigators for HF trials. We hypothesized that other types of U.S. providers may represent a rich pool of potential HF site investigators. Methods Using an integrated U.S. medical and pharmacy claims database of primarily commercial insurers, we reviewed 2016-17 claims data. We used ICD-10 codes to identify patients with HF with reduced ejection fraction (HFREF) and HF with preserved ejection fraction (HFPEF). We also identified HFREF and HFPEF providers and the rates of hospitalization of their HF patients. We analyzed provider use of ACE inhibitors, angiotensin receptor blockers (ARBs), and sacubitril/valsartan for HFREF and used this as a marker for quality of care. Results Based on medical and pharmacy claims, we identified 1,978,060 patients with HFREF and 1,508,726 patients with HFPEF in the U.S. Of HFREF patients, 0.5% received care from advanced HF/transplant cardiologists, 39% from cardiologists, and 25% from by internists ( Figure ). Of HFPEF patients, 0.2% received care from advanced HF/transplant cardiologists, 34% from cardiologists, and 30% from internists. Hospitalizations for HFREF by provider specialty were as follows: 1) advanced HF/transplant cardiologists (59%); 2) cardiologists (55%); and, 3) internists (64%). Use of ACE inhibitors, ARBs, or sacubitril/valsartan HFREF patients by provider specialty was as follows: 1) advanced HF/transplant cardiologists (49%); 2) cardiologists (47%); and, 3) internists (35%). Conclusions In this analysis, a quarter of HFREF patients and a third of HFPEF patients in the U.S. received care from internists. Less than half of HF patients cared for by providers of any specialty received guideline-based therapy with ACE inhibitors, ARBs, or sacubitril/valsartan. These results suggest that internists may represent a rich pool of potential site investigators for HF clinical trials. A combination of patient volume, use of guideline-based HF therapies, and other clinical trial metrics should be used to identify the most qualified HF site investigators, regardless of specialty.