PHARMacy‐based interdisciplinary program for patients with Chronic Heart Failure (PHARM‐CHF): rationale and design of a randomized controlled trial, and results of the pilot study

Abstract

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119.

Highlights in heart failure

“…214,215 Precipitating factors may be found in most of the cases of acute HF, and they may also have a prognostic role. 47,57,90,150,[219][220][221] This is consistent with the relatively high proportion of patients who have an early rehospitalization for non-cardiac causes. 15, [216][217][218] Multiple factors may contribute to the poor outcomes of the patients after the hospitalization for acute HF, including socioeconomic factors, poor patient support, and poor adherence to prescribed medications.…”

Pharmacy‐based interdisciplinary intervention for patients with chronic heart failure: results of the PHARM‐CHF randomized controlled trial

“…PHARM‐CHF was an investigator‐initiated, prospective multicentre, randomized controlled study. The study design has been published previously . In brief, patients aged 60 years and older with CHF defined by HF symptoms, currently treated with a diuretic, and a hospitalization for HF within the last 12 months or increased B‐type natriuretic peptide or N‐terminal pro‐B‐type natriuretic peptide concentrations, were recruited by study physicians.…”

“…The primary composite safety endpoint was days lost due to unplanned cardiovascular hospitalizations (blindly adjudicated) or all‐cause death. Secondary safety endpoints were percentage of days lost due to unplanned cardiovascular hospitalizations or death of any cause, all‐cause mortality or unplanned cardiovascular hospitalizations as recurrent event, unplanned cardiovascular hospitalizations, unplanned hospitalizations for HF, days lost due to hospitalizations of any cause or death, unplanned all‐cause hospitalizations, and all‐cause mortality …”

August 2019 at a glance: arrhythmogenic cardiomyopathy, biomarkers of inflammation, insulin treatment, initiation of sacubitril/valsartan, and pharmacy‐based intervention to increase medication adherence

“…Adherence to evidence‐based medications is an independent prognostic factor and a major goal of treatment . PHARMacy‐based interdisciplinary programme for patients with Chronic HF (PHARM‐CHF) was a randomized controlled trial to assess the efficacy of a pharmacy‐based intervention on medication adherence . The primary endpoint was medication adherence assessed as proportion of days covered (PDC) within 365 days for three classes of HF medications (beta‐blockers, angiotensin‐converting enzyme inhibitors or angiotensin receptor blockers, and mineralocorticoid receptor antagonists).…”