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Heart Failure clinical trials

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NCT ID: NCT03955029 Not yet recruiting - Clinical trials for Chronic Heart Failure

Interval Training in Heart Failure

PROVO2MAX
Start date: May 2019
Phase: N/A
Study type: Interventional

Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Because of the repeated hospitalizations of this disease, it is considered a costly pathology and with a high mortality rate (23.000 deaths per year in France). Moreover, HF is a severe pathology that affects the quality of life of patients and their families. Treatment and medical follow-up are required. A cardiac rehabilitation program is also a primary indication according to the latest recommendations and repositories in Cardiology. Various studies show that "Interval Training" exercise program improves VO2 peak compared to a "continuous" program, which constitutes a major prognostic factor in the population of heart failure. However, it is sometimes a difficult program to offer to more deconditioned patients as it requires reaching powers around 80% - 95% of its maximum exertion capacity. So, a variant of the interval training is offered, called Progressive Interval Training (PIT), based on the same model as the conventional interval training (CIT), but with an increasing power and breathing threshold, so that the patient can adapt gradually. The hypothesis is that PIT could improve VO2 peak better than CIT in cardiac rehabilitation program. Therefore, study the benefits of PIT training to improve the conditioning and quality of life of patients with chronic heart failure will be studied.

NCT ID: NCT03951467 Not yet recruiting - Clinical trials for Acute Myocardial Infarction

Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations

ILIADE
Start date: September 2019
Phase: N/A
Study type: Interventional

Health literacy is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. Health literacy is known as a health determinant. Level of Health Literacy (HL) is low or limited within 47% of interrogated people in Europe, resulting in an inability to understand and/or use written texts and digital concepts about one's health. There is a demonstrated link between low HL and low therapeutic adherence, an increase in the number of re-admissions, and more generally poor health or survival that is even more limited. An association between low LS and higher health care costs has also been reported in the USA and Switzerland. WHO highlight the central role of LS in health inequalities, regardless of the region of the world. We chose to conduct this study in patients hospitalized for an acute cardiovascular event: acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF), as these patients have cumulative risk factors for misuse and medication errors. They are hospitalized in emergency, for shorter and shorter periods and are discharged with complex drug treatments. The data show that the return home after acute hospitalization for these conditions is a particularly high-risk period for medication errors and misuse, especially with low HL. The proportion of patients with preventable ADR in the weeks following their return home ranges from 23% to 30% and nearly 60% are re-hospitalized within 6 months. Our hypothesis is that in patients hospitalized for AMI or ADHF with low HL levels, information on discharge treatment using appropriate tools and techniques will reduce the risk of patient-related medication errors or misuse within 30 days of discharge. The purpose of this study is to develop an educational intervention model adapted to low HL levels and routinely feasible, even in case of short stays, in complementarity with traditional therapeutic education programmes that require higher investments and are therefore not accessible to all patients. This innovative approach could then be applied to a large number of chronic diseases.

NCT ID: NCT03949309 Not yet recruiting - Clinical trials for Acute Myocardial Infarction

Pilot Study of ILIADE : Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events

P-ILIADE
Start date: June 1, 2019
Phase:
Study type: Observational

Health literacy (HL) is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. Health literacy is known as a health determinant. An association has been shown between low health literacy and low health outcomes such as increased number of unscheduled hospitalization or emergency visits, low medication adherence and poor health status. These have been particularly demonstrated with cardiovascular diseases, which combine risk factors (emergency hospitalization, reduction in the length of hospital stays, and complex secondary preventive drug treatments). Despite many scientific international literature about health literacy and health outcomes, no information is available in France on the prevalence of low health literacy level of patients, notably cardiovascular patients. The investigating team's hypothesis is that knowing the prevalence of low HL levels in cardiovascular patients would help to better tailored a communication intervention dedicated to the needs of these low-HL patients with the final aim of increasing their adhesion to preventive drugs and behavioural recommendations. The first aim of the present study is to estimate the prevalence of low HL level among patients discharged after acute myocardial infarction or acute decompensation of chronic heart failure. Secondary aims are to assess factors associated with the level of HL and identify barriers and facilitators of low HL patients to understand medical information on their disease. The results of this study will guide the design of the intervention of an interventional study on HL of cardiovascular patients.

NCT ID: NCT03948685 Not yet recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Carvedilol SR Study for Biomarkers From Blood and Urine and Safety of in Patients With Heart Failure With Preserved Ejection Fraction

Start date: May 2019
Phase: Phase 4
Study type: Interventional

Beta blockers have been used to reduce the mortality and heart failure rehospitalization in heart failure with reduced ejection fraction (HFrEF) patients in addition to ACEI/ARB, MRA, ivabradine and ARNI. However, the effective and safe medical therapy is not well established in heart failure with preserved ejection fraction (HFpEF) yet. Recent meta-analysis showed that beta blockers may also be beneficial for reducing the mortality and heart failure rehospitalization in HFpEF like HFrEF. However, the clinical effect and safety of carvedilol have been largely unknown in HFpEF. Therefore, CAYMUS HFpEF is the exploratory study to assess the change of surrogate markers (NTproBNP, hsTn) when treated with carvedilol SR vs. placebo in HFpEF patients

NCT ID: NCT03947983 Not yet recruiting - Heart Failure Clinical Trials

Sensor-controlled Digital Game for Heart Failure Self-management

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in older adults with heart failure (HF). Half of the participants will receive the SCDG app and weight monitoring and physical activity sensors and the other half will receive only the weight monitoring and physical activity sensors.

NCT ID: NCT03947853 Not yet recruiting - Heart Failure Clinical Trials

Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure

THETIS
Start date: June 1, 2019
Phase:
Study type: Observational

Cardiac Heart Failure Questionnaire HF-Q) to assess the severity of the symptoms of Heart Failure. In this study, modified and translated, the "four-point" questionnaire by Severo and his associates - Heart Failure Questionnaire HF-Q, is used. The HF-Q Heart Failure Questionnaire consists of four closed questions: the first with four possible answers and the other three questions with the possibility of three simple-choice answers.

NCT ID: NCT03945968 Not yet recruiting - Stroke Clinical Trials

The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.

STOP RISK
Start date: July 1, 2019
Phase:
Study type: Observational

Study is conducted to assess the prevalence and structure of comorbidity among patients undergoing abdominal surgery and produce the stratification of the risk of postoperative complications by identifying independent predictors for its development.

NCT ID: NCT03945058 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure

TECO-HF
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Heart failure (HF) is the leading cause of death in US. It is associated with abnormal vascular function termed endothelial dysfunction. It is also associated with increased stress on the blood vessels and high levels of inflammation. Vagus nerve stimulation can help improve inflammation, vascular function and vascular stress. The investigator has recently completed a study showing that 1 hour of noninvasive vagus stimulation can improve vascular health. However, it is unknown if 8 weeks of stimulation will be beneficial in systolic heart failure. The purpose of this study is to determine if transcutaneous vagal stimulation (TVS) will lead to improvement in the function of the inner lining of participants' arteries, memory, and in the levels of certain chemical markers of arterial function in the blood. Participants will be randomized to receive either TVS or a sham stimulation and undergo 8 weeks of stimulation. Vascular function will be assessed by several non-invasive measurements, including Flow Mediate Dilation (FMD), Pulse Wave Analysis (PWA), EndoPAT, and Laser Speckle Contrast Imaging (LSCI). Participants' memory will also be measured through electronic assessments and blood will be collected and analyzed for arterial function chemical markers.

NCT ID: NCT03942978 Not yet recruiting - Heart Failure Clinical Trials

Reducing Structural Inequities in Heart Failure Management: An Approach to Improve the Quality of Heart Failure Care on the General Medicine Service: Longitudinal Equity Action Plan (LEAP)

Start date: May 31, 2019
Phase: N/A
Study type: Interventional

Recent institutional research has demonstrated that black and Latinx patients are significantly less likely to be admitted to cardiology and more likely to be admitted to general medicine for their inpatient heart failure (HF) care. Subsequent HF care on general medicine has been demonstrated to have worse outcomes including lower rates of follow-up with cardiology and higher readmission rates. Given this, this project is a institutional quality improvement initiative, with a stepped wedge design, with the aim to improve the quality of care for heart failure patients admitted to general medicine for their care, and improve discharge planning. General medicine services by hospital pods will be enrolled in a stepped wedge fashion to a Longitudinal Equity Action Plan (LEAP) which includes a standardized clinical management plan to ensure patients are on guideline-appropriate therapy, receive cardiology consultation if appropriate, are discharged when clinically appropriate, discharge planning and systematic follow up with cardiology, transportation support as needed for follow-up visits, post-discharge follow up to identify any post-discharge issues.

NCT ID: NCT03938090 Not yet recruiting - Heart Failure Clinical Trials

Optimised MultiSite Pacing Vector Study

Start date: July 2019
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to evaluate the clinical benefits of an MultiSite pacing (MSP) with patient specific left ventricular vector optimization in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy. This clinical investigation is a single-center, prospective, two-arm, randomized 1:1, crossover study designed to evaluate the effectiveness of Optimized MSP CRT compared to conventional bi-ventricular pacing. Data will be collected at enrolment, CRT implant procedure, hospital pre-discharge, one, three and six months post implant. Enrolment data collection will include demographics, cardiovascular history, medication, echocardiography measurements, heart failure quality of life questionnaire and six minute walk test distance. CRT implant procedure data collection will include implanted system information, lead location and conduction times. The electrical conduction recording procedure will include surface ECG and device electrogram (EGM) recordings during various MSP vector pacing configurations at the time of CRT device implant. Patients will also undergo simultaneous invasive pressure measurements using a left ventricular pressure wire to allow haemodynamic measurements (dP/dtmax) during various MSP vector pacing configurations. Optimal MSP programming settings will be determined by the narrowest QRS duration recorded by 12 lead ECG and the greatest change in dP/dtmax by pressure wires study. In a subgroup of patients (approximately 25 patients), non-invasive electrical activation data will be collected with electrocardiographic imaging (ECGi) within 45 days of the implant procedure. Patients will then be randomized 1:1 to receive either standard biventricular pacing or Optimized MSP at their one-month follow-up (± 15 days) visit. At the 3 months (± 15 days) post randomization follow up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. The patients will then undergo cross-over to the alternate randomization group with programming adjusted accordingly. At the final, 6 months (± 15 days) post randomization follow-up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. This will mark the completion of the study for each patient. The expected duration of enrolment is 18 months. The total duration of the clinical investigation is expected to be 25 months.