HEART INITIATIVE INC

DURING 2025 THE HEART INITIATIVE HAS CONTINUED TO SUMMARIZE AND ANALYZE ASSESSING THE IMPLEMENTATION OF APPROVED, GENERIC MEDICATION FOR THE TREATMENT OF HF IN PATIENTS RECENTLY ADMITTED FOR ACUTE HEART FAILURE. THE RESULTS OF THE STUDY WERE ANALYZED, PRESENTED, AND PUBLISHED. THEY ARE EXPECTED TO HAVE SIGNIFICANT IMPACT ON THE TREATMENT OF HEART FAILURE, A DISEASE THAT INFLICTS APPROXIMATELY 6 MILLION AMERICANS AND IS ASSOCIATED WITH HIGH MORBIDITY AND MORTALITY. IN ADDITION, THE HEART INITIATIVE IS ACTIVELY CONTINUING TO ANALYZE AND PUBLISH DATA FROM THE COMPLETED STUDIES BOTH CONDUCTED IN SUB-SAHARAN AFRICA. IN 2024, THE HEART INITIATIVE ALSO CONDUCTED THE CORTAHF STUDY THAT ASSESSED THE USE OF STEROIDS IN PATIENTS WITH AHF AND PUBLISHED THE MAIN RESULTS. THE STUDY EVALUATED THE SAFETY AND EFFICACY OF A 7-DAY "BURST" OF PREDNISONE IN PATIENTS HOSPITALIZED WITH ACUTE HEART FAILURE (AHF) AND HIGH INFLAMMATORY MARKERS. MISSION AND ACCOMPLISHMENTS: IN 2025, THE HEART INITIATIVE CONTINUED ITS SCIENTIFIC MISSION TO ADVANCE HEART FAILURE THERAPY WORLDWIDE THROUGH TWO PRIMARY AVENUES: 1. PUBLICATIONS AND DATA DISSEMINATION: THE INITIATIVE FOCUSED ON PUBLISHING AND SHARING DATA FROM STUDIES COMPLETED IN PRIOR YEARS, ENSURING THAT FINDINGS WERE BROADLY DISSEMINATED TO THE SCIENTIFIC COMMUNITY. SEVERAL EXAMPLES OF THIS WORK AUTHORED BY CONTRIBUTING MEMBERS OF OUR RESEARCH ORGANIZATION ARE HIGHLIGHTED IN THE PUBLICATIONS LINKED BELOW: HTTPS://PUBMED.NCBI.NLM.NIH.GOV/36356631/ 2. PERFORMING STUDIES TO PROMOTE BETTER HEART HEALTH GLOBALLY, THE HEART INITIATIVE HAS CONTINUED TO SPONSOR ITS LARGEST STUDY TO DATE: THE STRONG-HF STUDY WHICH IS AIMED AT BETTER IMPLEMENTING CHEAPER GENERIC THERAPIES IN PATIENTS POST DISCHARGE FROM A HOSPITAL FOR HEART FAILURE. IN 2022, THE HEART INITIATIVE SECURED ADDITIONAL SPONSORSHIP FROM ROCHE DIAGNOSTICS TO ENABLE EXPANDING THE STUDY TO UP TO 1,100 PATIENTS AND CONTINUES TO RECRUIT PATIENTS TO THE STUDY GLOBALLY IN EUROPE, SOUTH AMERICA AND SUB-SAHARAN AFRICA. IN 2022, THE STUDY WAS COMPLETED AND ANALYZED, PRESENTED AND PUBLISHED. 3. THE HEART INITIATIVE WITH ITS PARTNERS AT ISNERM HAVE INITIATED A NEW STUDY TO EXPLORE THE EFFECTS OF STEROIDS IN AHF. THE STUDY TITLE IS "EFFECT OF SHORT-TERM PREDNISONE THERAPY ON C-REACTIVE PROTEIN CHANGE IN EMERGENCY DEPARTMENT PATIENTS WITH ACUTE HEART FAILURE AND ELEVATED INFLAMMATORY MARKERS". ACUTE HEART FAILURE (AHF) IS A COMMON DISCHARGE DIAGNOSIS IN THE EMERGENCY DEPARTMENT (ED), ASSOCIATED WITH 1-MONTH MORTALITY OF 6%, AND A 30% RISK RATE OF 1-MONTH REHOSPITALIZATION. CURRENT GUIDELINES RECOMMEND THE USE OF NITRATES AND LOW DOSE DIURETIC TO TREAT CONGESTION, BUT TO DATE, NO DRUG HAS EVER SHOWN ANY IMPROVED CLINICAL OUTCOME WHEN GIVEN AT THE ACUTE PHASE. SEVERAL STUDIES SUGGEST THAT THERE IS A HIGH INFLAMMATORY COMPONENT IN AHF, WITH ELEVATED MARKERS SUCH AS IL6 AND C-REACTIVE PROTEIN (CRP). AS IT IS THE CASE IN OTHER ACUTE RESPIRATORY DISEASE, A SHORT COURSE OF STEROID THERAPY MAY LIMIT THE INFLAMMATORY RESPONSE AND IN TURN, IMPROVE AHF PROGNOSIS. THE OBJECTIVE OF THE STUDY IS TO ASSESS THE EFFECT OF A 7-DAY COURSE OF STEROID INTRODUCED IN THE ED ON INFLAMMATORY RESPONSE. THE STUDY IS A PARALLEL-GROUP, RANDOMIZED, OPEN-LABEL, CONTROLLED TRIAL IN 5 EDS IN FRANCE. PATIENTS WITH AHF AND HIGH CRP LEVELS WILL BE RANDOMIZED TO 7 DAYS OF PREDNISONE THERAPY OR CONTROL AND FOLLOWED FOR 30 DAYS. ENDPOINTS INCLUDE CHANGE IN CRP LEVELS AND RISK OF WORSENING HF, HF READMISSION OR DEATH TO DAY 30. 4. THE HEART INITIATIVE AND ITS PARTNERS IN MOUNT SINAI HOSPITAL IN NYC HAVE INITIATED A STUDY TO ASSESS WAYS TO IMPROVE ADHERENCE IN PATIENTS WITH HTN AND HYPERLIPIDEMIA. THE STUDY ENTITLED: "CP&R - CARDIOVASCULAR PRECISION MEDICINE & REMOTE INTERVENTION". CONTROL OF HYPERTENSION AND HYPERCHOLESTEROLEMIA IS KEY TO REDUCING RISK OF ADVERSE CARDIOVASCULAR OUTCOMES IN PATIENTS WITH CARDIOVASCULAR MORBIDITY. NON-ADHERENCE TO MEDICAL RECOMMENDATIONS IS THE MOST IMPORTANT REASON FOR ADVERSE OUTCOMES, AS BLOOD PRESSURE REMAINS ERRATIC IF MEDICATION-TAKING IS ALSO ERRATIC. NON-ADHERENCE CAN BE IDENTIFIED BY MULTIPLE SUBJECTIVE AND OBJECTIVE METHODS, BUT SUBJECTIVE METHODS (PATIENTS' OWN REPORTS) ARE NOT RELIABLE, AND OBJECTIVE METHODS MAY BE MISLEADING (IF THEY ARE DEPENDENT ON FACTORS OTHER THAN ADHERENCE), OR CUMBERSOME. FOR EXAMPLE, ELECTRONIC MONITORING OF ADHERENCE TENDS TO REQUIRE THE USE OF A SPECIFIC DEVICE, AND THE MOST NON-ADHERENT PATIENTS TEND NOT TO BE ABLE TO CONSISTENTLY USE THE DEVICE, RESULTING IN STUDY DESIGNS THAT FAVOR ADHERENT PATIENTS (IN STUDIES THAT PURPORT TO IMPROVE ADHERENCE). THE PRESENT STUDY USES A NOVEL INDICATOR FOR NON-ADHERENCE BASED ON ELECTRONIC HEALTH RECORD (EHR) DATA: THE DEGREE OF VARIABILITY OF BLOOD PRESSURE MEASUREMENTS OVER TIME. RISK STRATIFICATION BY A VARIABILITY MARKER WILL BE COUPLED WITH REMOTE INTERVENTION OFFERED ONLY TO PATIENTS WHO ARE AT INCREASED RISK. THE INTERVENTION WILL BE TARGETED AT THE POSSIBLE ROOT CAUSES OF THESE PATIENTS' NON-ADHERENCE. THE INNOVATIONS IN OUR APPROACH ARE THE USE OF A MARKER DERIVED FROM EHR INFORMATION TO TARGET THE INTERVENTION (RESULTING IN BETTER RESOURCE ALLOCATION), THE REMOTE INTERVENTION THAT DOES NOT REQUIRE IN-PERSON MEETINGS WHICH MAY BE HARD TO IMPLEMENT ESPECIALLY WITH PATIENTS WHO ARE NON-ADHERENT TO THEIR MEDICAL RECOMMENDATIONS ANYWAY, AND THE FLEXIBLE AND ADAPTABLE INTERVENTION THAT IS CUSTOMIZED FOR EACH PATIENT. 5. THE HEART INITIATIVE INITIATED A NEW STUDY, ROBUST HF, WHICH WILL HELP IMPLEMENT THE RESULTS OF STRONG HF GLOBALLY. THE STUDY WAS THE MAIN FOCUS OF THE HEART INITIATIVE IN 2024.