Heart Failure Clinical Trial
Official title:
Triage of Reduced Exercise Tolerance in Frail Elderly
Background 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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|