Clinical trials

Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis. The goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity. The trial aims to answer the following questions: * Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test. * Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch? * Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire. Researchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily. Participants will: * Join the study voluntarily after signing a consent form. * Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery. * Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring. * Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.

Introduction: Prone position (PP) treatment as a rescue strategy for patients with acute respiratory distress syndrome (ARDS) is a technique increasingly used in our daily practice and, as a result of the current health situation due to SARS COV-2, has become the treatment of choice for many patients. Many of the associated complications can be considerably reduced with the implementation of standardized procedures and a team trained and specialized in this technique and its subsequent care. Aim: To evaluate the efficacy of the use of Hyperoxygenated Fatty Acids (HOFA) compared to the use of hydrocolloid dressings (HCD) in the prevention of Pressure ulcers (PUs) occurrence in critically ill patients in prone position. Methods: A randomized clinical trial will be conducted to compare the occurrence of PUs and other complications in patients undergoing PP in the ICU of the HUPHM. Two care groups will be formed in which HOFA and hydrocolloid dressings will be used, respectively, following a strict care protocol previously established in the unit. In addition, other variables related to medical and nursing treatment that may influence the appearance of PUs and other complications associated with PP will also be analyzed. Scientific relevance: PUs have a major socioeconomic and quality of life impact on patients. Dressings and topical agents for prevention are widely used, however, it is unclear which treatment is most effective in preventing PUs in the prone patient. Keywords: Prone Position; Nursing care; Pressure ulcer; Fatty acids; Prevention; Complications.

Patients with abnormalities of the biliary tract (the system that connects the liver to the small intestine and allows bile to flow) are prone to the development of strictures, dilations, or other problems that impede bile flow and promote the formation of gallstones. All of this leads to the development of infections in this anatomical region known as cholangitis. These infections typically require the patient to be admitted to the hospital, either to a general ward or even the ICU. These are, therefore, serious infections that threaten the patient's survival. Unfortunately, one-quarter of these patients experience not just one, but multiple infections of this type over an extended period of time. This condition is called acute recurrent cholangitis (ARC). It is important to note that the antibiotics used to treat these repeated infections lead to the selection of more resistant and virulent bacteria that remain in the intestine for months or years and, in turn, promote the recurrence of these infectious episodes. ARC affects a more vulnerable population, which, combined with the proliferation of resistant bacteria, increases the risk of serious complications and a reduced response to available treatments. Replacing these dangerous gut bacteria with bacteria from healthy donors is a strategy that has proven effective in reducing recurrent urinary tract infections. A similar approach has been successful in patients with chronic vaginal infection (vaginosis). This gut microbiota replacement is currently being investigated for a wide range of diseases affecting various sites, with promising results in some cases. There is strong evidence that this strategy may also be effective in patients with recurrent episodes of cholangitis. The procedure is considered very safe and is subject to strict safety measures to prevent risks to the recipient of these bacteria (requirements similar to those used for blood transfusions). If this strategy proves effective, it could reduce patient suffering and even mortality, as well as save money spent on hospital stays and medications, and contribute to reducing antibiotic use and the emergence of bacterial resistance. Even if no significant clinical benefit is demonstrated in this clinical setting, the information obtained will contribute to increasing knowledge about the role of the fecal microbiota, the technical and scientific aspects of fecal microbiota transplantation, and its potential uses. It should be noted that a patient association called ALBI España (Association for the Fight Against Inflammatory Biliary Diseases) has participated in the study's design and strongly supports this research, which could lead to a reduction in mortality among its patients and a reduction in adverse effects and costs associated with hospital admissions and antibiotic use. In summary, the use of FMT in patients with AC could have a significant impact on treatment effectiveness, reducing new episodes of cholangitis. This would improve patients' quality of life-including their physical, emotional, and social well-being-by reducing hospitalizations and associated complications. Another clear benefit would be the reduction in the proliferation of resistant bacteria and a lower use of antibiotics. The use of TMF would increase the autonomy of the National Health System (SNS) by enabling it to develop and manage non-commercial, non-profit therapies with low production costs, which would guarantee equitable access for patients to an effective and safe therapy.

The aim of the study is to evaluate whether a tailored cardiac rehabilitation program, initiated during hospitalization and continued after discharge, can improve functional capacity, mobility, and quality of life in patients over 65 years old with heart failure.

The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors. The main question it aims to answer is whether there is a difference in natriuresis 24 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).

Digestive cancers account for a substantial proportion of oncological patients, representing over 20% of cases treated in hospitals, and are generally managed through a multidisciplinary approach that has markedly improved survival outcomes over recent decades. Surgical resection remains the cornerstone of curative treatment, often preceded by neoadjuvant chemotherapy, radiotherapy, or combined modalities. Notably, a significant proportion of patients eligible for abdominal surgery are older adults, with approximately one in three being over 75 years of age. Advances such as Enhanced Recovery After Surgery (ERAS) protocols and the centralization of complex surgical procedures have contributed to better outcomes, including higher rates of radical resections, improved survival, reduced postoperative complications, and shorter hospital stays. While some risk factors are non-modifiable, such as age, sex, tumor stage, comorbidities, and tumor biology, several modifiable factors can be optimized prior to surgery to improve postoperative outcomes. These include smoking cessation, enhancement of aerobic capacity and muscular strength, nutritional optimization, emotional resilience, and correction of anemia or other metabolic derangements. Preoperative exercise, ideally embedded within a multimodal prehabilitation program, is recommended for all patients undergoing major surgery. The neoadjuvant period represents a valuable window to implement trimodal prehabilitation strategies encompassing physical exercise, nutritional support, and psychological interventions, aimed at reducing postoperative complications, shortening hospital length of stay, and improving functional recovery. Physical fitness in this context is multidimensional, encompassing aerobic capacity, muscle strength, and body composition. Aerobic capacity predicts postoperative complications and length of hospital stay, while low muscle strength and sarcopenia are associated with higher morbidity and poorer prognosis. Inspiratory muscle training can further reduce pulmonary complications and accelerate recovery. Nutritional status is a critical determinant of surgical outcomes in gastrointestinal cancer, with malnutrition affecting up to 80% of patients at diagnosis. Comprehensive assessment, including dietary intake, anthropometric measurements, physical examination, and biomarkers such as albumin and transferrin, is essential, and targeted interventions including protein supplementation, pancreatic enzyme replacement, or tailored dietary strategies should be implemented when indicated. Body composition, particularly sarcopenia and cachexia, is closely linked to both nutrition and exercise, and can be assessed through imaging techniques such as DXA, CT, or MRI, or via bioelectrical impedance in research settings, with simpler bedside assessments used in clinical practice. Emotional wellbeing also plays a significant role, as preoperative anxiety and depression can negatively influence recovery, adherence to rehabilitation, and overall quality of life. Psychological support, stress management, and behavioral interventions can improve patient engagement and enhance outcomes. The physiological principles of hormesis and cross-stressor adaptation suggest that controlled exercise can improve resilience to both physical and psychological stressors, including the stress of surgery itself. Additional modifiable factors such as absolute cessation of alcohol and tobacco, glycemic control in diabetic patients, correction of anemia (including iron deficiency), and frailty assessment in older adults are critical components of preoperative optimization. Major abdominal surgery carries substantial risk, including infections, bleeding, and anastomotic complications, which directly impact quality of life and lengthen hospitalization. Evidence from randomized controlled trials indicates that multimodal prehabilitation effectively reduces postoperative complications and shortens hospital stay. However, motivating patients to engage in exercise during neoadjuvant therapy can be challenging due to treatment-related fatigue, nausea, and other side effects. Integrating behavioral theories such as Self-Determination Theory and the Theory of Planned Behavior can enhance intrinsic motivation by fostering autonomy, competence, and relatedness, and addressing attitudes, subjective norms, and perceived behavioral control, ultimately promoting adherence to prehabilitation programs and optimizing postoperative recovery.

Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of Sacubitril/Valsartan (Sac/Vals) compared to no initiation of the drug in patients with transthyretin cardiac amyloidosis (ATTR) and heart failure with reduced ejection fraction (LVEF ≤40%). The primary objective is to determine the impact of Sac/Vals treatment on systolic function by assessing the change in LVEF on echocardiogram at 12-month follow-up.

The goal of this national multicenter prospective cohort study is to learn about the added value of 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose) PET-CT in invasive fungal disease management. The main questions it aims to answer are: 1. Does the use of 18F-FDG PET-CT allow a better characterization of invasive fungal infection (IFI) (performance) compared to the exclusive use of conventional radiological studies in terms of extension/staging and monitoring of response/follow-up ? 2. Does the systematic and protocolized use of 18F-FDG PET-CT in IFI allow a better management of patients with IFI and increase the prognostic value of the initial evaluation? Participants will undergo systematically a 18F-FDG PET-CT as part of the work-up of their invasive fungal disease. Researchers will compare the performance of 18F-FDG PET-CT with standard management without 18F-FDG PET-CT to see if adds value (diagnostic, prognostic, and changes in management).