Active clinical trials for "Heart Failure"

A quasi-experimental and comparative study will be conducted in two different geographical areas (Europe-France and Africa-Cameroon) on a period of 18 months. All eligible adults aged 50 years and older presenting to one of the investigative centers (for HIV care) will be included in the study. The patients will be randomized in two parallel groups according to the 1:1 ratio, namely a control group A where patients continue the usual HIV management, and an intervention group B where in addition to the usual HIV management, patients will benefit from an adapted physical activity (APA) program for three months. An evaluation of heart rate variability, response to current treatment, gut microbiota profile and quality of life will be performed at the end of the APA session. Comparison between control group A and intervention group B will be performed. The acceptability of this program will also be evaluated.

An application (app) called the activity coach will be tested to see if it can increase physical activity and decrease sedentary behaviuor, as well as increase quality of life and lead to personal goal attainment in physically inactive heart failure (HF) patients. This pilot randomized controlled trial (RCT) will test the study design and recruitment process, as well as outcomes for a future efficacy RCT. HF-patients equipped with the mHealth-tool Optilogg will be screened for physical inactivity and then recruited and randomized to either have the activity coach app added to their Optilogg or remain with the standard Optilogg. The study will go on for 12 weeks. Weeks 1 and 12 physical activity using an accelerometer will be recorded, as well as health-related quality of life. At the start of the study the patients will list goals relating to physical activity which the wish to attain, and the level of attainment will be evaluated at the end of the study. The activity coach educated the patient about physical activity, offers means of manually tracking physical activity, and provides trends of registered activity. Furthermore, it provides weekly summaries of registered physical activity and provides means of setting goals for the following week.

Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Renal impairment which co-occurs in patients with heart failure is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight. The participants stayed at the trial site for about 6 days. During this time, the doctors took blood and urine samples and checked the participants' health. About 7-14 days after the participants took vericiguat (BAY1021189), the researchers checked the participants' health again and asked about any medical problems they had.

Background: This study was carried out to determine the effect of physical activity program applied to individuals with heart failure on quality of life, functional capacity and mortality risk level. Objective: The study, which was conducted as a randomized controlled experimental study, was completed with a total of 40 HF patients, 20 of whom were interventions and 20 were controls. A physical activity program lasting at least 30 minutes each session was applied to HF patients in the intervention group, three days a week for three months, and the walks of the patients were followed by a pedometer.

A randomized parallel single-center clinical trial, blinded for the evaluation of the outcomes and statistical analysis. The current hypothesis is that PEAC-IC will improve self-care behavior, knowledge about heart failure, health-related quality of life, and the number of hospitalizations and searches for emergency services in the participants with heart failure.

Researchers are looking for a better way to treat heart failure, a condition in which the heart does not pump blood as well as it should. Heart failure can happen in both adults and children. The study treatment, vericiguat, is already available for doctors to give to adults who have heart failure. It works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. The current form of vericiguat is a tablet that releases the "active substance" immediately. The "active substance" is the part of the drug that works in the body to treat the condition. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure, but think it will be easiest for them to take a liquid treatment. Another study is planned to find out how well vericiguat works in children who have a specific type of heart failure. Before researchers can give vericiguat to children, they must first study different doses and ways of taking vericiguat in adults. In this study, the researchers will study a new liquid form of vericiguat in adults. This form is also known as the "pediatric formulation". In this study, the researchers want to find out how the new pediatric formulation of vericiguat moves into, through, and out of the body compared to the currently approved tablet form for adults. The researchers also want to find out if eating food affects the new pediatric formulation differently than the current tablet form of vericiguat. The study will include about 36 healthy white male participants aged between 18 and 45 years old. During this study, the participants will all take 4 different treatments in different orders. They will take: a high dose of vericiguat in the new pediatric formulation, with food a high dose of vericiguat in the new pediatric formulation, without food a low dose of vericiguat in the new pediatric formulation, with food a dose of the currently available tablet form, with food While taking each study treatment, the participants will stay at the study site for 4 days. There will be a break of at least 10 days between each treatment. Overall, the participants will be in this study for about 11 weeks. During the study, the participants will: have blood and urine samples taken have their overall health and heart health checked answer questions about how the new pediatric formulation tastes answer questions about any adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of primary and secondary hypertension and heart failure. Pfizer Inc. is the marketing authorization holder for prazosin HCl oral capsules and intended to transfer drug product manufacturing operations from Pfizer, Barceloneta Puerto Rico to Pfizer Pharmaceutical, Ascoli, Italy. To support the manufacturer site transfer and process changes, this bioequivalence (BE) study is being conducted. This study will be a 2 Cohort, open-label, randomized, single dose study in healthy adult male and/or female participants. Cohort 1 will be crossover with 3 treatments, 3 periods, 6 sequences. Cohort 2 will be crossover with 2 treatments, 2 periods, 2 sequences. Primary objective of this study is demonstrate bioequivalence between prazosin HCl 1, 2 and 5 mg capsules manufactured at Ascoli versus prazosin HCl 2 and 5 mg capsules manufactured at Barceloneta under fasting conditions in healthy adult participants. Approximately 36 participants will be enrolled in each Cohort 1 and Cohort 2. Pharmacokinetic and statistical analysis will be performed for prazosin. Data from 2 Cohorts will be analyzed separately. The PK parameters area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast), and from time zero extrapolated to infinite time (AUCinf), maximum plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), and terminal phase elimination half-life (t½) will be summarized descriptively by analyte and treatment. For primary objective, bioequivalence of the Test treatment relative to Reference treatment will be concluded if the 90% confidence intervals (CI) for the ratio of adjusted geometric means of Test treatments relative to Reference treatment for AUCinf (if data permit), AUClast and Cmax, fall wholly within (80%, 125%).

Patients with Chronic Heart Failure diagnosed and conventional treated, but still symptomatic (i.e. breathlessness, fatigue) is invited. Eligible patients are randomised to (1) care as usual (i.e. optimized medical treatment) or (2) care as usual (i.e. optimized medical treatment) in combination with an 8-week mindfulness-based educational and training program. Specific research questions: How are self-reported symptoms of breathlessness, fatigue, difficult sleeping, anxiety and depression affected by a mindfulness-based educational and training program (MBI)? Does the implementation of an 8-week Mindfulness-based program have any impact on personal experiences of well-being and health? What effects does an 8-week MBI have on objective signs of importance for the progression of heart failure?

Researchers are looking for a better way to treat people with heart failure. Heart failure is a condition which occurs when the heart does not pump blood as well as it should leading to shortness of breath, tiredness, and ankle swelling. The study treatment BAY1753011 is under development to treat heart failure. It is thought to reduce the action of a hormone called vasopressin that is naturally produced in the body. People with heart failure often have elevated levels of vasopressin. This is known to result in worsening of the heart failure condition. People with heart failure often also have reduced kidney functions. As kidneys play a role in removal of drugs from the body, reduced kidney function may result in higher blood levels of BAY1753011. The main purpose of this study was to learn how BAY1753011 moved into, through and out of the body in participants with different degrees of reduced kidney function compared to matched participants (age, gender, and weight) with normal kidney function. To answer this, the researchers compared: the (average) total level of BAY1753011 in the blood (also called AUC) the (average) highest level of BAY1753011 in the blood (also called Cmax) between the different groups with reduced kidney function (mild/moderate/severe) and the control group (normal kidney function). In addition, the researchers wanted to know how safe BAY1753011 was and the degree to which overt medical problems caused by it could be tolerated (also called tolerability) by the different groups of participants. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. All participants took a single dose of BAY1753011 in tablet form by mouth. Each participant was in the study for approximately 3 to 4 weeks, including an in-house phase of 5 days and 4 nights with one treatment day. During the study, the doctors and their study team: did physical examinations checked vital signs such as blood pressure, heart rate, body temperature and number of breaths within a minute (respiratory rate) examined heart health using electrocardiogram (ECG) took blood and urine samples counted the number of toilet visits during the night

Advance care planning (ACP) represents a process whereby a patient, in consultation with healthcare professionals, family members and important others, makes decisions about his or her future healthcare and wishes for end-of-life care and is widely advocated to improve end-of-life care for patients with heart failure (HF). Despite the growing emphasis on communication with HF patients and their relatives, there is no tradition in Denmark for systematical communication about wishes for end-of-life care. The aim of the study is to adapt the ACP to a new contest and target group and determine the feasibility and acceptable recruitment rate and completeness of potential outcome measures for a future RCT. A study of a complex intervention will be conducted to address all elements of an adapted ACP intervention in HF patients (NYHA class III, IV) and their relatives. Patients will be identified and recruited by HF specialist nurses or a cardiologist from the Department of Cardiology at North Zealand Hospital. The HF specialist nurses or the cardiologist will inform the patients about the study and obtain consent for the research staff to contact the patients by telephone. The patients will be further informed by the research staff and asked to fill out the baseline questionnaires. The patients will be asked to select the closest relatives who also will be offered participation. Included patients will receive an invitation with the date and time of their ACP meeting in their electronic patient record. They will be offered an ACP discussion which covers components e.g. symptom control, discussions on prognosis and illness limitations, and wishes for future and end-of-life care. Baseline and follow-up (4 and 12 weeks after the ACP meeting) will be made with disease-specific and generic questionnaires. Qualitative interview data will be obtained, and thematic analysis will uncover the patients, relatives and the clinician's perspectives and satisfaction with the intervention.