Repurposing Probenecid for the Treatment of Heart Failure (Re-Prosper-HF): a study protocol for a randomized placebo-controlled clinical trial.

BACKGROUND: Improving contractility in heart failure with reduced ejection fraction (HFrEF) has resurfaced as a potential treatment goal. Inotropic therapy is now better understood through its underlying mechanism as opposed to the observed effect of increasing contractility. Calcitropes are a subgroup of inotropes that largely depend on the stimulation of adenylyl cyclase to transform ATP into cyclic adenosine monophosphate (cAMP). At least two clinically relevant calcitropes-istaroxime and probenecid-improve contractility through an increase in systolic intracellular calcium without activating cAMP production. Probenecid, which has been safely used clinically for decades in non-cardiac conditions, has recently been identified as an agonist of the transient receptor potential vanilloid 2 channel. Translational studies have shown that it improves calcium cycling and contractility without activating noxious pathways associated with cAMP-dependent calcitropes and can improve cardiac function in patients with HFrEF. METHODS: The Re-Prosper-HF study (Repurposing Probenecid for the Treatment of Heart Failure with Reduced Ejection Fraction) is a three-site double-blinded randomized-controlled trial that will test the hypothesis that probenecid can improve cardiac function in patients with HFrEF. Up to 120 patients will be randomized in this double-blind, placebo-controlled study that will assess whether oral probenecid administered at 1 g orally twice per day for 180 days in patients with NYHA II-III HFrEF improves systolic function (aim 1), functional status (aim 2), and self-reported health status (aim 3). DISCUSSION: Findings from this study will provide data informing its use for improving symptomatology in patients with HFrEF as well as exploratory data for outcomes such as hospital admission rates. TRIAL TEGISTRATION: The Re-Prosper HF Study (Re-Prosper HF) is registered on ClinicalTrials.gov with the identifier as NCT04551222. Registered on 9 September 2020.

Healthcare providers experiences with shared medical appointments for heart failure.

Shared medical appointments (SMAs) offer a means for providing knowledge and skills needed for chronic disease management to patients. However, SMAs require a time and attention investment from health care providers, who must understand the goals and potential benefits of SMAs from the perspective of patients and providers. To better understand how to gain provider engagement and inform future SMA implementation, qualitative inquiry of provider experience based on a knowledge-attitude-practice model was explored. Semi-structured interviews were conducted with 24 health care providers leading SMAs for heart failure at three Veterans Administration Medical Centers. Rapid matrix analysis process techniques including team-based qualitative inquiry followed by stakeholder validation was employed. The interview guide followed a knowledge-attitude-practice model with a priori domains of knowledge of SMA structure and content (understanding of how SMAs were structured), SMA attitude/beliefs (general expectations about SMA use), attitudes regarding how leading SMAs affected patients, and providers. Data regarding the patient referral process (organizational processes for referring patients to SMAs) and suggested improvements were collected to further inform the development of SMA implementation best practices. Providers from all three sites reported similar knowledge, attitude and beliefs of SMAs. In general, providers reported that the multi-disciplinary structure of SMAs was an effective strategy towards improving clinical outcomes for patients. Emergent themes regarding experiences with SMAs included improved self-efficacy gained from real-time collaboration with providers from multiple disciplines, perceived decrease in patient re-hospitalizations, and promotion of self-management skills for patients with HF. Most providers reported that the SMA-setting facilitated patient learning by providing opportunities for the sharing of experiences and knowledge. This was associated with the perception of increased comradery and support among patients. Future research is needed to test suggested improvements and to develop best practices for training additional sites to implement HF SMA.

Group medical visits after heart failure hospitalization: Study protocol for a randomized-controlled trial.

A primary goal of this research project is to better understand how shared medical appointments (SMAs) can improve the health status and decrease hospitalization and death for patients recently discharged with heart failure (HF) by providing education, disease state monitoring, medication titration, and social support to patients and their caregivers. We propose a 3-site randomized-controlled efficacy trial with mixed methods to test a SMA intervention, versus usual care. Patients within 12 weeks of a HF hospitalization will be randomized to receive either HF-SMA (intervention arm) with optional co-participation with their caregivers, versus usual care (control arm). The HF-SMA will be provided by a non-physician team composed of a nurse, a nutritionist, a health psychologist, a nurse practitioner and/or a clinical pharmacist and will consist of four sessions of 2-h duration that occur every other week for 8 weeks. Each session will start with an assessment of patient needs followed by theme-based disease self-management education, followed by patient-initiated disease management discussion, and conclude with break-out sessions of individualized disease monitoring and medication case management. The study duration will be 180 days for all patients from the day of randomization. The primary study hypothesis is that, compared with usual care, patients randomized to HF-SMA will experience better cardiac health status at 90 and 180 days follow-up. The secondary hypotheses are that, compared to usual care, patients randomized to HF-SMA will experience better overall health status, a combined endpoint of hospitalization and death, better HF self-care behavior, and lower B-type natriuretic peptide levels.

A Description of Patient and Provider Experience and Clinical Outcomes After Heart Failure Shared Medical Appointment.

BACKGROUND: Shared medical appointments (SMAs) are clinical visits in which several patients meet with 1 or more providers at the same time. OBJECTIVE: To describe the outcomes of an interdisciplinary SMA for veterans recently discharged for heart failure (HF). METHODS: A retrospective chart review for patients' readmission rates, survival, medication adherence, and medication-related problems. For qualitative outcomes, we performed semistructured interviews on 12 patients who had undergone HF SMAs and their respective caregivers focusing on care satisfaction, HF knowledge, disease self-care, medication reconciliation, and peer support. RESULTS: The cohort comprised 70 patients-49% had left ventricular function <40% and 50% were prescribed >10 medications. Medication-related problems occurred in 60% of patients. Interviews revealed overall satisfaction with HF-SMA, but patients felt overwhelmed with HF instructions, perceived lack of peer support and self-efficacy, and feelings of hopelessness related to HF. CONCLUSION: Shared medical appointments are well-perceived. Medication problems and need for medication management are prevalent along with patient's lack of self-efficacy in HF care. Multiple HF-SMA visits may be needed to reinforce concepts, reduce confusion, and garner peer support.