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Heart Failure, Congestive clinical trials

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NCT ID: NCT03519477 Not yet recruiting - Clinical trials for Heart Failure,Congestive

Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

Start date: July 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.

NCT ID: NCT03497871 Recruiting - Clinical trials for Heart Failure, Congestive

Personal Decision Support System for Heart Failure Management

HeartMan
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Despite the availability of evidence-based guidelines for disease management in patients with congestive heart failure (CHF), the uptake of these guidelines in clinical practice is sub-optimal and adherence rates are disappointing. Within the HeartMan project, a personal e-health system was developed to help CHF patients manage their disease, with the ultimate goal to improve health-related quality of life (HRQoL). The system uses wrist-band sensors to monitor patients' physical activity and physiological parameters. These data are connected to a decision support system, providing medical advice to patients concerning physical exercise, nutrition, medication intake, clinical measurements, environment management, and mental support. The decision support system is based on predictive models, clinical care guidelines and expert knowledge. The advice will be personalized according to each individual patient's medical and psychological profile, and will be presented to the patient through the user interface of a mobile application on a smartphone. A proof of concept trial with a 1:2 (control:intervention) randomization protocol was designed. The sample size calculation was based on primary outcome data from the previous CHIRON project, showing that 90 patients are needed to show at least -5.8 (± 6 to 8 s.d.) beats/min difference in average daily awake heart rate difference - as a fundamental parameter correlating with patient reported HRQoL - with 90% power between the two groups. Data collection will include an estimation of exercise capacity based on a six-minute walking test, and questionnaire assessments using standardized instruments. The trial will be initiated in two countries. In order to account for possible dropouts, 60 patients will be enrolled in Italy and 60 in Belgium (20 control and 40 intervention patients in each country). Target patients are stable ambulatory CHF patients (NYHA class 2-3; reduced left ventricular ejection fraction ≤40%). Eligible patients will be recruited by their treating physician from collaborating medical centers in both countries; they will be enrolled in the trial after giving informed consent for participation. After baseline assessment, patients will be randomized into either the intervention (duration of 6 months) or control (usual care) condition. Data collection will be repeated at the end of the trial.

NCT ID: NCT03425422 Not yet recruiting - Heart Failure Clinical Trials

ANTHEM-HFrEF Pivotal Study

Start date: April 2018
Phase: N/A
Study type: Interventional

A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.

NCT ID: NCT03389386 Recruiting - Clinical trials for Heart Failure,Congestive

Plasma Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure

CATSTAT-HF
Start date: January 25, 2018
Phase:
Study type: Observational

The congestive heart failure (HF) is a condition associated with substantial morbidity, mortality, and high healthcare expenditures. From the pathophysiological standpoint, several mechanisms contribute to the progression and dysfunction of the failing heart such as an increased hemodynamic overload, impaired myocyte calcium cycling, upregulated apoptotic activity, deficient or increased production of extracellular matrix, genetic predilections and, finally, excessive neurohumoral stimulation. The vasoactive neurohumoral systems such as sympathetic nervous system, renin-angiotensin-aldosterone system (RAAS) and arginine vasopressin (AVP) system all play a role in maintaining volume and circulatory homeostasis in the situation of impaired cardiac output. Catestatin (CST), on another hand, is a novel endogenous peptide cleaved from chromogranin A (CgA) that is involved in regulation of cardiac function and arterial blood pressure. The role of this peptide is to elicit potent catecholamine release-inhibitory activity by acting at the level of the nicotinic acetylcholine receptors. Therefore, the main hypothesis of this study is that the observed plasma CST levels will reflect the degree of neurohormonal activation in HF, showing a significant relationship with the degree of disease severity (according to NYHA classification). The investigators expect that among participants with worst clinical phenotypes of HF, CST levels in plasma will be highest and will decrease as the disease severity decreases. Secondly, the investigators expect to observe the significant correlation between CST levels in plasma with the echocardiographic parameters of the ventricular function, both in terms of systolic and diastolic cardiac function. Parameters of inflammation, NT-proBNP levels and basic hematologic/biochemistry indices from peripheral blood will also be obtained and analyzed from all the participants enrolled in the study. Furthermore, according to the latest European Society of Cardiology (ESC) guidelines, participants with established congestive HF will be prospectively stratified in three categories in respect to their left ventricular ejection fraction (LVEF) - HFrEF, HFmrEF, HFpEF. All the examined echocardiographic and blood parameters will be recorded and compared with respective healthy and matched control participants while participants diagnosed with HF will additionally be analyzed for potential differences between subgroups according to their LVEF value.

NCT ID: NCT03387813 Recruiting - Heart Failure Clinical Trials

Hemodynamic-GUIDEd Management of Heart Failure

GUIDE-HF
Start date: March 15, 2018
Phase: N/A
Study type: Interventional

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

NCT ID: NCT03385837 Recruiting - Clinical trials for Cardiac Rehabilitation

Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients

Start date: March 1, 2015
Phase: N/A
Study type: Observational

A prospective longitudinal and observational clinical study will be conducted with hospitalized heart failure patients.The main purpose is to know the level of physical activity of these patients after their discharge in relation to the orientation received during their hospitalization and identify the barriers perceived by these patients to participate in a cardiac rehabilitation program. The outcomes are available by telephone calls in 30 and 90 days after discharge.

NCT ID: NCT03341156 Not yet recruiting - Clinical trials for Heart Failure,Congestive

Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation

OPSTAHT
Start date: June 20, 2018
Phase: Phase 3
Study type: Interventional

This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.

NCT ID: NCT03237858 Recruiting - Clinical trials for Heart Failure, Congestive

Multiple Cardiac Sensors for the Management of Heart Failure

MANAGE-HF
Start date: August 15, 2017
Phase: N/A
Study type: Interventional

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

NCT ID: NCT03202329 Not yet recruiting - Clinical trials for Heart Failure,Congestive

Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Patients with heart failure NYHA >= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)

NCT ID: NCT03200860 Recruiting - Clinical trials for Heart Failure,Congestive

Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure

EMPA-RESPONSE
Start date: December 18, 2017
Phase: Phase 2
Study type: Interventional

Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes, This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.