Heart Failure Clinical Trial
Official title:
Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial
Verified date | August 2015 |
Source | InCor Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
Exposure to air pollution is associated with increase in cardiovascular morbidity and mortality. Controlled human exposure studies have demonstrated impaired vascular function and heart rate variability on healthy volunteers. The aim of this study is to investigate the effects of reducting diesel exhaust inhalation on endothelial function, heart rate variability and cardiopulmonary stress testing in healthy volunteers and patients with chronic heart failure, by using a filter mask.
Status | Completed |
Enrollment | 45 |
Est. completion date | January 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - NYHA I-III; - Left Ventricle Ejection Fraction < 50%; - Clinical condition stable for more than three months prior to the randomization; Exclusion Criteria: - Severe arterial hypertension; - Severe Pulmonary disease; - Patients with pace-markers; - Patients with constrictive pericarditis; - Severe chronic kidney disease; - Patients with pulmonary hypertension; - Stroke within the last six months; - Severe hepatic disease; - Patients with musculoskeletal limitations to exercise; - Patients with cardiac cachexia. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Brazil | Heart Failure Lab. Incor HCFMUSP | São Paulo |
Lead Sponsor | Collaborator |
---|---|
InCor Heart Institute | Fundação de Amparo à Pesquisa do Estado de São Paulo, LABORATÓRIO DE INSUFICIÊNCIA CARDÍACA E TRANSPLANTE INCOR/HCFMUSP, LABORATÓRIO DE POLUIÇÃO ATMOSFÉRICA EXPERIMENTAL (LPAE/ FMUSP). |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelial Function | Endothelial function assessment is based on an endothelially mediated arterial response at the distal phalanx of a finger, in response to a five-minute occlusion of the brachial artery. Arterial stiffness is assessed by a finger plethysmographic probe. | six months | Yes |
Secondary | Heart rate variability | Heart rate variability (HRV) analysis attempts to assess cardiac autonomic regulation through quantification of sinus rhythm variability. Heart rate and beat-to-beat intervals are recorded using a frequency counter Polar Electro Oy - 800 model, interfaced to a microcomputer, and assessed using standard time domain analysis. | six months | Yes |
Secondary | Inflammatory Markers | After each exposure, we collected blood samples for inflammatory variables—including circulating leukocytes, serum C-reactive protein, B-type natriuretic peptide, Troponin and Catecholamines. | 12 months | Yes |
Secondary | Six-minute walking test | Exercise testing is performed on a treadmill using a modified Naughton protocol and the 6 minute walk test. Ventilation, oxygen uptake, and carbon dioxide production are monitored continuously using a respiratory mass spectrometer. | Six months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
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
|