Braunau Am Inn

Researchers are studying real-world patient characteristics, treatment patterns, and both short- and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM across the United States and Europe. The study focuses on patients receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or prior treatment failure. The U.S. portion evaluates the safety of mavacamten in this setting, while the European part assesses both its effectiveness and safety. Participants receive treatments as part of standard care, either mavacamten or other medications such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide. Treatments are prescribed by physicians according to routine clinical management. The study observes outcomes over time without altering prescribed care. During the study, participants are monitored for changes in heart function, symptoms, and adverse events through clinical assessments including echocardiography and patient-reported questionnaires. Researchers evaluate heart failure events, heart function measures like left ventricular outflow tract gradient and ejection fraction, arrhythmias, hospitalizations, mortality, and quality of life scores. Data is collected at baseline and followed for up to five years to understand real-world treatment effects and safety.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Transthyretin amyloid cardiomyopathy ATTR-CM is a condition where a protein called transthyretin TTR breaks down and forms harmful clumps called amyloid, which deposit in the heart wall and impair its ability to pump blood properly. This can lead to heart failure and may be caused by age-related changes or genetic factors. Researchers are studying acoramidis, a drug that attaches to TTR to stabilize it and reduce amyloid formation, in participants who were previously treated with tafamidis, another TTR stabilizer. The goal is to see if switching to acoramidis increases blood TTR levels beyond those achieved with tafamidis. Participants will take acoramidis as two 356 mg tablets twice daily by mouth for up to 6 months. Before starting, all participants will continue their tafamidis treatment during a screening period. The study involves a single treatment group receiving acoramidis, and the main measurement is the change in serum TTR levels from baseline to 6 months or earlier if treatment stops. Secondary measures include heart function markers, kidney and thyroid assessments, and quality of life scores. Participants will be involved in nine check-ins, including two visits at the study site at screening and the end of treatment, six home visits by a study nurse during the first month and at 3 months, and a final phone check-in. Assessments include electrocardiograms, blood pressure, heart rate, and collection of blood and urine samples to monitor various health markers. The total participation time is about 8 months, during which researchers will monitor safety and treatment effects closely.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are conducting the Austrian Hypertrophic Cardiomyopathy HCM Registry, a prospective study enrolling patients from multiple outpatient clinics across Austria, including academic and non-academic centers. The registry aims to collect detailed clinical data on patients with HCM to facilitate innovative epidemiological analyses and improve standards of care by understanding gaps in evidence for this heart condition. Participants undergo a structured examination process that includes assessment of HCM symptoms, medical and family history, medication use, and specific red flags related to HCM. Clinical data collected include electrocardiograms, echocardiography, laboratory tests, and genetic testing. All information is entered into an electronic case report form to support multicenter analyses approved by a steering committee. During the study, patients will be followed over an average of 20 years with ongoing collection of data related to all-cause mortality and cardiovascular events. The registry supports cross-sectional and longitudinal analyses, aiming to harmonize clinical care for HCM patients in Austria. The total participation time depends on continued follow-up and data collection throughout the study duration.

Researchers are studying metastatic colorectal carcinoma mCRC patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.

Researchers are evaluating the efficacy and safety of the drug levosimendan, taken orally, 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 measure the change in the 6-Minute Walk Distance, which reflects exercise capacity. This phase 3, randomized, double-blind study aims to improve understanding of treatment options for this condition. About 540 participants will be randomly assigned in a 21 ratio to receive either oral levosimendan or a matching placebo. Those who complete the initial study period of 26 weeks may be eligible to join an open-label extension lasting 52 weeks, during which all participants can receive levosimendan. The study carefully monitors participants throughout both phases to assess the effects of the treatment. Participants will undergo various assessments including the 6-Minute Walk Distance test, questionnaires like the Kansas City Cardiomyopathy Questionnaire to evaluate health status, and classification of physical ability using the New York Heart Association scale. Screening includes heart catheterization, echocardiograms, ambulatory heart rhythm monitoring, and exercise testing. Safety and clinical worsening events will be tracked. The total involvement may last beyond a year for those in the extension phase, ensuring thorough evaluation of outcomes and safety.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are studying metastatic breast cancer, the most common cancer among women worldwide, with a focus on patients in Austria. This study is the first Austrian-wide registry to systematically collect and document data on metastatic breast cancer cases. The aim is to understand epidemiological trends and treatment patterns, including tumor characteristics and patient outcomes. The study collects both retrospective and prospective data from multiple centers across Austria. It records detailed information on tumor subtypes, initial disease progression, treatment sequences, and patient medical histories. This registry also includes data on male breast cancer patients to assess gender differences in treatment and outcomes. Participants provide anonymized medical information, including tumor characteristics, treatment details, and survival data. Researchers will analyze patterns of metastasis, treatment responses, and survival rates at 1, 2, and 5 years after metastasis diagnosis. The registry aims to offer insights into treatment quality and outcomes over a 10-year period.