Braunau Am Inn

Researchers are studying patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the United States and Europe to understand their characteristics, treatment patterns, and outcomes over time. The study focuses on individuals who are receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or failure of prior therapies. The research includes a United States sub-study to evaluate mavacamten's safety and a European sub-study to assess both its effectiveness and safety in real-world settings. Participants may receive mavacamten according to its product label or other symptomatic therapies such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide based on standard care. The study includes those starting mavacamten, currently on other treatments, or untreated due to intolerance or failure of prior therapy. Treatment is observed during routine clinical care without altering prescribed therapy. Data collection occurs over several years to monitor long-term outcomes. During the study, participants will be regularly assessed for heart function and symptoms, including measuring the left ventricular outflow tract gradient and monitoring the incidence of new or worsening heart failure up to five years. Researchers will gather information on patient health, treatment safety, and heart function changes through echocardiography and symptom evaluations. The study allows for long-term observation to better understand real-world treatment effects and outcomes in obstructive HCM patients.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a condition where a protein called transthyretin (TTR), made by the liver, breaks down and forms harmful clumps called amyloid in the heart. This buildup affects the heart's ability to pump blood properly and can lead to heart failure. The study focuses on adults with either the wild-type or genetic variant of ATTR-CM who were previously treated with the drug tafamidis, aiming to evaluate changes in blood TTR levels after switching to a different drug called acoramidis. Participants in this phase 4 study will take acoramidis tablets orally at a dose of two 356 mg tablets twice daily, totaling 1424 mg per day, for up to 6 months. All participants will continue taking tafamidis during a screening period before switching to acoramidis. The study is designed as a single-arm trial where everyone receives acoramidis, and the main goal is to assess whether acoramidis increases blood TTR levels beyond those achieved with tafamidis. Throughout the study, participants will have 9 check-ins including two visits to the study site (screening and end of treatment), six home visits by a study nurse during the first month and at 3 months, and a final phone call. Researchers will evaluate heart, kidney, and thyroid function with tests such as electrocardiograms, blood pressure and heart rate measurements, blood and urine samples collected at various times. The primary outcome is the change in serum TTR levels from the start of treatment to 6 months or earlier if treatment stops. Each participant's total involvement is expected to last about 8 months.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are conducting the Austrian Hypertrophic Cardiomyopathy (HCM) Registry, a prospective multicenter study enrolling patients from various outpatient clinics across Austria, including both academic and non-academic centers. The study focuses on patients with hypertrophic cardiomyopathy, aiming to collect detailed clinical and genetic data to improve understanding and care standards for this condition. The registry supports innovative research and facilitates both cross-sectional and long-term epidemiological analyses to identify evidence gaps in HCM management. Participants will undergo a structured examination that includes evaluation of HCM symptoms, medical and family history, medication use, and detection of HCM-specific warning signs. Clinical assessments will involve electrocardiograms, echocardiography, laboratory tests, and genetic testing. Data collected will be entered into an electronic case report form to enable multicenter data analysis, overseen by a steering committee with representatives from each site. During the study, researchers will monitor all-cause mortality and cardiovascular events over an average follow-up period of 20 years. The study involves ongoing data collection and standardized clinical assessments to harmonize care for HCM patients in Austria. Data access for research requires approval by the steering committee, ensuring regulated use of the information collected throughout the study duration.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are studying the drug levosimendan taken orally to evaluate its safety and effectiveness compared to a placebo in adults with pulmonary hypertension associated with heart failure with preserved left ventricular ejection fraction (PH-HFpEF). The main goal is to see if levosimendan improves exercise ability, measured by the change in the distance walked in six minutes. This is a Phase 3 clinical trial involving approximately 540 participants. Participants will be randomly assigned in a 2:1 ratio to receive either oral levosimendan or a matching placebo. After the initial study period, those who qualify may join an open-label extension lasting 52 weeks to continue receiving the study drug. The study carefully monitors the participants' health and responses during these phases. Throughout the trial, participants will undergo various assessments including right heart catheterization, echocardiograms, and a six-minute walk test to measure exercise capacity. Heart rhythm will be monitored using a 48-hour ambulatory cardiac monitor during screening. Safety and effectiveness are tracked over at least 26 weeks, with the primary measurement being the six-minute walk distance. Participants may be followed for up to a year if they enter the extension phase.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.