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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.

(last updated: Nov 28, 2022)

Clinical Trials Information

27 Results - per page

DatabaseTitleRecruitmentConditionsInterventionSponsored ByGenderAge GroupsPhasesStudy TypeSummaryStart Date
Clinicaltrials.gov
Triage of Reduced Exercise Tolerance in Frail ElderlyCompletedHeart Failure, Chronic Obstructive Pulmonary DiseaseOther - Index groupUMC Utrecht, ZonMw: The Netherlands Organisation for Health Research and Development, Other, Other65 Years - N/AN/AInterventionalBackground of the study: Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and social functioning. Patients commonly attribute this symptom to their age, and simply adjust their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative impact on the quality of life and are associated with frequent hospital admissions. Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in primary care. Establishing a diagnosis early in the course of the disease is useful because both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic triage-strategy followed bij direct treatment would be of great importance to asses and treat heart failure and COPD in elderly patient with shortness of breath. Objective of the study: Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the difference in prevalence of unrecognised COPD and heart failure between those who underwent the diagnostic triage compared to those who received care as usual. Quantify the effect of the diagnostic triage plus the additionally treatment changes on functionality and quality of life after 6 months compared to those who received care as usual. Quantify the cost-effectiveness of the diagnostic triage strategy compared to care as usual Study design: A clustered randomized diagnostic (follow-up) study Study population: First, pre-selection of patients aged over 65 years from 50 general practices is based on frailty. Frailty is based on the next criteria: use 5 or more different types of medical drugs chronically in the last year and/or have 3 or more chronic or vitality treating diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done from the electronic medical files of the general practices. These elderly will receive the MRC questionnaire of dyspnoea and three additional questions related tot exercise intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to participate, except those with established heart failure and COPD. Study parameters/outcome of the study: Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure and COPD between both groups. Differences in functionality and quality of life after 6 months between both groups. Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.
Clinicaltrials.gov
An Integrated Solution for Sustainable Care for Multimorbid Elderly Patients With DementiaNot yet recruitingComorbidities and Coexisting Conditions, Alzheimer Disease, Dementia, Malnutrition, Frailty, Sarcopenia, Stroke, Asthma, Chronic Obstructive Pulmonary Disease, Chronic Kidney Diseases, Heart Failure, Diabetes, Coronary Artery Disease, Hypertension, Behavioral SymptomsOther - Intervention tested (CAREPATH)Complejo Hospitalario Universitario de Albacete, ECLEXYS SAGL, FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V., Klinikum Bielefeld, University of Warwick, University Hospitals Coventry and Warwickshire NHS Trust, University of Castilla-La Mancha, CENTRUL IT PENTRU STIINTA SI TEHNOLOGIE, SRDC YAZILIM ARASTIRMA VE GELISTIRME VE DANISMANLIK TICARET ANONIM SIRKETI, OCTILIUM SAGL, Other, Other, Other, Other, Other, Other, Other, Other, Other, Other65 Years - N/AN/AInterventionalThe CAREPATH will conduct Technical Validation and Usability (TVU) study by involving ≥ 45 target end users (16 patients with MCI or mild dementia with their informal caregivers and 16 healthcare professionals from various disciplines) and Clinical Investigation (CI) study involving ≥ 200 patients (≥ 100 users to pilot the CAREPATH platform and ≥ 100 patients as reference cases). Both of these pilot studies will be coordinated in four European countries (Spain, Romania, Germany and UK) with diverse health and social care systems, ICT landscape/digital maturity of healthcare provision and dementia national programs, which will allow for strengthening the evidence base on health outcomes and efficiency gains. The CAREPATH outcomes can be summarized as: 1. An Integrated Care Platform that jointly addresses multimorbidity, dementia and diminished intrinsic capacity and optimally manages healthcare interventions for its users (patients, informal caregiver, healthcare providers, etc). 2. Technical Validation and Usability (TVU) study involving over 45 users and Clinical Investigation (CI) involving over 200 patients that will be conducted in four European countries (Spain, Romania, Germany and UK) during two years and mobilizing the other necessary actors, such as caregivers and healthcare professionals, for the validation of healthcare interventions. 3. Dementia / Multimorbidity Guidelines that will be conceived for best healthcare delivery. 4. Health Economics Impact Assessment for healthcare cost effectiveness and care provision equalities. The incremental cost-effectiveness and the incremental cost-utility ratio would allow revealing the incremental cost (or the potential savings) per unit of benefit of switching from usual care to CAREPATH-an integrated patient-centred approach- in multimorbid elderly patients with dementia, and therefore, to determinate whether the CAREPATH approach would be considered as a cost-effective alternative.
Clinicaltrials.gov
Development of Specific Diagnostic Tools for Cardiac Insufficiency With Preserved Ejection FractionRecruitingHeart FailureOther - Blood sampling, questionnaires and specific examsUniversity Hospital, Montpellier, Other65 Years - N/AObservationalThe MeDIAGSTOLE project aims to develop diagnostic tools for heart failure with preserved ejection fraction (IC / FEp), a pathology that is difficult to diagnose and to manage clinically in the absence of targeted treatment . The IC / FEp concerns the elderly population with comorbidities such as hypertension, obesity, anemia and atrial fibrillation. In the absence of specific biomarkers, clinical diagnosis is based on serum markers of heart failure with reduced ejection fraction (IC / FEr). The identification of new biomarkers, genetic and / or cellular, specific for IC / FEp would be an important innovation.
Clinicaltrials.gov
Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary StudyCompletedCoronary Disease, Stroke, Chronic Kidney Disease, Heart Failure, Diabetes Mellitus, Hypertension, HypercholesterolemiaBehavioral, Behavioral - Copayment Elimination, Personalized EducationUniversity of Calgary, Alberta Innovates Health Solutions, Other, Other65 Years - N/AN/AInterventionalThe purpose of this study is to determine the effect of two novel interventions; (1) a value-based formulary which eliminates copayment for selected high-value medications (proven to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient education program aimed at lifestyle modification and optimal drug use, combined with relay of information on medication use, on the risk of adverse clinical outcomes (mortality, heart attack, stroke, need for coronary revascularization, and chronic disease related hospitalizations) in low-income seniors with chronic conditions over three years of follow-up or until March 31, 2021 (whichever comes first).
Clinicaltrials.gov
Randomized Clinical Trial of a Pharmaceutical Care Program in Chronic Patients Users of an Emergency DepartmentCompletedHeart Failure, Pulmonary Disease, Chronic ObstructiveOther, Other - Pharmaceutical Care Program, Standard CareFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Other65 Years - N/AN/AInterventionalThe study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.
Clinicaltrials.gov
Telemedicine Technology Demonstration Project for Heart FailureCompletedHeart FailureOther - TelemedicineProvidence Health & Services, Verizon Wireless, Other, Industry65 Years - N/AN/AInterventionalThe purpose of this study is to see if telemedicine can help improve the health of patients with heart failure who have recently been hospitalized with heart problems, and are being discharged to a Skilled Nursing Facility. Telemedicine uses electronic communications to make patient/doctor visits possible from a distance. This study will use remote video to allow heart failure specialists at Providence St. Vincent Medical Center to provide clinical health care to patients at Marquis Hills. Electronic monitors (including an electronic scale and blood pressure machine), and phone calls with the Marquis Hill nursing staff will be used to track patients' health status. The nursing staff will provide the heart failure specialists with daily updates on patients' symptoms, weight, vital signs (heart rate, blood pressure, pulse), and results of blood tests. Additionally, some patients will be provided with monitoring devices that include an iPhone blood pressure monitor, and Smart Body Analyzer to use for 14 days. The Smart Body Analyzer measures weight, body fat percentage, and heart rate. It also measures indoor air quality. Special software on the iPhone will save this information and the information will be transmitted by secure email to the study doctors. Hypothesis: The patients followed by telemedicine will have fewer visits to the Emergency Department, fewer deaths, and fewer hospital re-admissions than last year's site-specific average for this patient population.
Clinicaltrials.gov
Pilot Study of Vitamin D Supplementation in Heart FailureCompletedHeart FailureDrug, Drug - Cholecalciferol, PlaceboFraser Health, Other65 Years - N/AN/AInterventionalThe purpose of this study is to determine if the methods are feasible for a larger clinical trial.The study will examine the relationship between vitamin D status, quality of life, pain and walking distance of individuals living with heart failure.
Clinicaltrials.gov
Prevalence of Amyloidosis in Heart Failure (PREVAMIC)Unknown statusHeart FailureDiagnostic Test, Diagnostic Test - Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP)., Proteinogram and serum immunoglobulins. Light chains free in serum -Freelite-. Immunofixation in serum and urineFundación Pública Andaluza para la gestión de la Investigación en Sevilla, Other65 Years - N/AObservationalTITLE: Study of Prevalence of Amyloidosis in Heart Failure: PREVAMIC. DESIGN: Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. 44 hospitals from Spain will participate. OBJECTIVES. PRIMARY: To estimate the current prevalence of different types of cardiac amyloidosis (CA) in patients with heart failure, aged 65 years and older, with LVH > 12 mm and any LVEF value, managed in Internal Medicine departments. SECONDARY: To describe the clinical, laboratory and echocardiographic features of patients with CA. To compare one-year readmissions and mortality rates in patients with and without CA. INCLUSION CRITERIA: Inpatients or outpatients with heart failure, aged ≥ 65 years, both genders, under the care of internists. They should have a NYHA Class II-IV, echocardiogram performed in the previous 24 months, any value of LVEF, LVH: septum or posterior wall > 12 mm, diuretic treatment in the last 6 months and NTproBNP> 1800 pg/ml or BNP> 400 pg/ml in acute hear failure, or NT-proBNP >600 pg/ml o BNP >150 pg/ml in stable condition. POPULATION: Heart failure outpatients or inpatients of Internal Medicine Services. It is expected to include around 450 patients. ANALYSIS: To calculate the prevalence of TTR-CA and other types of CA. To compare the clinical, analytical, echocardiographic, and readmissions and mortality rates during one-year in patients with and without CA.
Clinicaltrials.gov
Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart FailureCompletedAtrial Fibrillation, Heart FailureOther - Non-InterventionalBristol-Myers Squibb, Industry65 Years - N/AObservationalObservational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners
Clinicaltrials.gov
Reducing Readmission for Frail Elderly Patients With Decompensated Heart FailureRecruitingHeart Failure, Acute Decompensated Heart Failure, Fragility, EmergenciesBehavioral, Other - Intervention Group, Control Group (Standard Care)Jewish General Hospital, Canadian Association of Emergency Physicians, Other, Industry65 Years - N/AN/AInterventionalA randomized study designed to determine whether telephone based interventions can prevent return hospital visits for elderly and frail patients with acute symptoms of heart failure. Specifically, the intervention will improve patients ability to monitor and address self care of heart failure at home.
Clinicaltrials.gov
Follow-up Strategies for Fragile Patients With Decompensated Heart FailureRecruitingHeart Failure, With Decompensation, FragilityOther - Management ProgramHospital Italiano de Buenos Aires, Other65 Years - N/AN/AInterventionalRandomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure.
Clinicaltrials.gov
Sodium Chloride and Contrast NephropathyCompletedKidney Failure, Chronic, Kidney Failure, Acute, Heart Failure, DiabetesDrug, Drug - Oral sodium chloride, Intravenous sodium chlorideHospital Universitario Ramon y Cajal, Other65 Years - N/APhase 2InterventionalThis phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast. Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol. Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study. Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.
Clinicaltrials.gov
Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older AdultsUnknown statusHeart Failure, Coronary Disease, Diabetes Mellitus, Asthma, Hypertension, HypercholesterolemiaOther - Community-based nurse care managementHealth Quality Partners, Centers for Medicare and Medicaid Services, Other, U.S. Fed65 Years - N/AN/AInterventionalCare coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established. This study investigates whether a community-based nursing intervention improves longevity and impact on cardiovascular risk factors in this population. The results reflect the impact of one of the study sites (Health Quality Partners) selected by the Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated Care Demonstration, a national demonstration designed to identify promising models of care coordination for chronically ill older adults. The study began in April 2002.
Clinicaltrials.gov
Pragmatic Trial of Video Education in Nursing HomesCompletedAlzheimer Disease, Dementia, Heart Failure, Pulmonary Disease, Chronic ObstructiveBehavioral - ACP Video ProgramBrown University, National Institute on Aging (NIA), Hebrew SeniorLife, Massachusetts General Hospital, Genesis HealthCare, PruittHealth, Other, NIH, Other, Other, Other, Other65 Years - N/AN/AInterventionalThis is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP Video Program, while the control NH facilities will follow their usual ACP procedures. The trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.
Clinicaltrials.gov
Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure OutcomesCompletedHeart FailureBehavioral - SurveyGeorgetown University, Other65 Years - N/AObservationalThe purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. The primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.
Clinicaltrials.gov
Pilot Deprescribing N-of-1 Trials for Beta-blockers in HFpEFEnrolling by invitationHeart Failure, Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Cardiac Failure, Heart DiseaseDrug - Beta blockersWeill Medical College of Cornell University, National Institute on Aging (NIA), Other, NIH65 Years - N/APhase 4InterventionalIn this study, we will test the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Heart Failure with Preserved Ejection Fraction. To achieve this objective we will conduct 16 4-period N-of-1 trials (on vs. off) and subsequently interview participants to better understand feasibility and pragmatism. The N-of-1 trials will be iteratively refined in real-time based on this feedback.
Clinicaltrials.gov
Balance Training for Elders With Heart FailureCompletedHeart FailureOther - Balance InterventionUniversity of Nebraska, American Nurses Foundation, Other, Other65 Years - N/AN/AInterventionalPurpose: The purpose of this pilot study is to evaluate the effect of a multi-component balance & resistance training [RT] intervention on physical function, balance, & falls in older [≥ 65 y/o] community dwelling heart failure [HF] patients. The study aims: 1] Pilot test multi-component balance activities & RT intervention on primary outcomes. 2] Explore perceptions related to outcomes & the intervention through focus groups. 3] Generate pilot data on adherence. 4] Generate pilot data on feasibility of conducting the BASIC Training intervention. Background/Significance: Falls are the leading cause of injury-related deaths in this group. Fall risks are even greater for those with HF due to decreased exercise capacity, loss of skeletal muscle & medication side effects. Though RT is effective for improving skeletal muscle, it has only a modest effect on improving balance, which is comprised of peripheral sensory input central integration, & motor output. A multi-component intervention focusing on balance retraining & strengthening the muscles supporting static/dynamic balance & functional mobility is necessary. Methods: Design - Randomized, two-group with wait list control, repeated measures experimental design. Sample/ Setting - 40-50 participants recruited from medical center heart failure clinic; supervised group sessions conducted in center's health & wellness center. Procedures - Participants will be randomized to intervention group or wait list control group. Focus groups pre/post intervention. The intervention will be administered in 1x per week supervised group sessions & 2x a week home sessions. Instruments - 30 Second Sit-to-St&, Modified Clinical Test of Sensory Interaction on Balance, Activity Specific Balance Confidence Scale, Timed Up & Go, Dynamic Gait Index. Analysis Plan: Aim 1- independent t-test to compare change scores from baseline to the end of the first 12 week period for the intervention group with the wait list control group. A second analysis will combine data from the delayed intervention period for the wait list control group with that from the first 12 week period for the intervention group to test change. Supplemental analysis, involving only data from intervention group, will test whether change is sustained at 24 weeks. Aim 2 - thematic analysis conducted with focus group data. Aim 3 - adherence assessed by group session attendance & home activities completed. Aim 4 - assess & report logistics of conducting the study. Nursing Relevance/Implications: This pilot study will initiate the process of developing a targeted intervention to induce changes in elderly HF patients to prevent future falls; thus reducing costs, physical & emotional burdens related to falls; & effect a major difference in the quality of life for this population.
Clinicaltrials.gov
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot StudyTerminatedAtrial Fibrillation, Heart FailureDrug, Device - FDA approved rate and rhythm control drugs, AV Node ablation and device implantMayo Clinic, Medtronic, Other, Industry65 Years - N/APhase 3InterventionalThe purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).
Clinicaltrials.gov
Multiparametric Telemonitoring In Elderly People With Chronic Heart FailureCompletedHeart FailureProcedure, Other - Telemonitoring, Standard careCampus Bio-Medico University, Other65 Years - N/AN/AInterventionalHeart failure is a chronic disease associated with an increasing risk of morbidity, disability, repeated hospitalizations and mortality. Telemedicine could promptly identify signs of worsening cardiac disease in order to improve elderly patients' home care and quality of life by reducing the need of hospital admissions and sanitary costs. The investigators present a randomized, parallel-group trial to test the ability of a multiparametric remote monitoring system, in addition to standard care, to promptly identify worsening of heart failure and prevent hospital admission and mortality.
Clinicaltrials.gov
Impact of Beta-blockers on Physical Function in HFpEFEnrolling by invitationHeart Failure, Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Cardiac Failure, Heart DiseaseDrug - Beta blockersWeill Medical College of Cornell University, The New York Community Trust, Other, Other65 Years - N/APhase 4InterventionalThe purpose of this study is to understand the impact of beta-blockers on physical function in older adults with heart failure. We will achieve this objective by conducting N-of-1 trials. N-of-1 trials are personalized experiments that test different treatment options in an individual patient.
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