Heart Failure Clinical Trial
— CLUSTER-HFOfficial title:
Efficacy of Lung Ultrasound Guided Therapy to Prevent Rehospitalizations in Heart Failure (CLUSTER-HF): a Randomized Controlled Trial
Verified date | December 2019 |
Source | Instituto Nacional de Cardiologia Ignacio Chavez |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Heart failure is the leading cause of hospitalization among adults >65 years of
age. Discharge from a heart failure hospitalization is followed by a 30 day readmission rate
of ≈24%. Readmissions for heart failure are typically preceded by a gradual rise in
ventricular filling pressures that begins days or weeks before any detectable changes in
clinical status.
Lung ultrasound (LUS) is a tool that is easily available at bedside and shows superior
sensitivity for the detection of pulmonary congestion when compared with X ray or physical
examination, even in the absence of symptoms.
Pulmonary congestion assessed by LUS identifies a subgroup with worse prognosis and a higher
rate of readmission and mortality. Whether the implementation of lung ultrasound in the
follow up of heart failure patients may reduce the rate of readmissions is unknown.
Objective: The aim of this study is to evaluate a protocol of lung ultrasound guided therapy
to prevent readmissions in heart failure outpatients.
Study design: the design of the investigator's study is a single center, single blinded,
randomized controlled clinical trial.
Eligibility criteria: patients older than 18 years of age, who have been hospitalized for an
acute heart failure syndrome. Exclusion criteria are life expectancy of less than 6 months, a
surgically correctable cause of heart failure or uninterpretable lung ultrasound.
Eligible patients will be randomized into either "LUS-guided therapy group" or "control
group" at hospital discharge. Follow-up visits will be scheduled at 15 days, 45 days, 3
months and 6 months after hospital discharge. LUS will be performed in all patients at
hospital discharge and in every follow-up visit, but only in those allocated to the
"LUS-guided therapy group" the information will be provided to the treating physician.
In the "LUS-guided therapy group", a prespecified diuretic dose will be administered to
patients depending on the degree of ultrasonographic pulmonary congestion: if congestive (3
or more B lines, in total) a high dose (80-120mg furosemide PO/day) will be prescribed; if no
congestive (less than 3 B lines, in total) a low dose (up to 40mg PO/day) will be prescribed.
Primary outcome will be the composite of hospital readmission + mortality. This study
complies with the Declaration of Helsinki and the study protocol is being evaluated by the
Ethic Committee of our institution.
Status | Completed |
Enrollment | 130 |
Est. completion date | December 7, 2019 |
Est. primary completion date | December 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients admitted to the hospital with the primary or secondary diagnosis of heart failure - The intra-hospital stay extends for at least 24 hours. - The patient shows new symptoms (or worsening of known symptoms) due to the presentation of heart failure, including at least one of the following: dyspnea (dyspnea at rest, at exertion, orthopnea, nocturnal paroxysmal dyspnea), decreased exercise capacity, fatigue or other symptoms of target organ hypoperfusion or volume overload. - The patient has at least two physical examination findings; or at least one finding to the physical examination and at least one complementary criterion, including: physical examination findings that are considered to be due to heart failure (peripheral edema, increase in the abdominal perimeter or ascites in the absence of primary liver disease, signs of pulmonary congestion including crackles, subcrepitant rales or decrease in vesicular murmur, increase in jugular venous pressure and / or hepatojugular reflux, gallop by third sound (S3) or rapid weight gain, clinically significant, attributed to water retention); and/or complementary findings that are considered to be due to heart failure, including Increase in levels of N-terminal-pro-BNP (NT-proBNP) compatible with decompensation of heart failure (> 2,000 pg / mL), radiographic evidence of pulmonary congestion, or invasive or non-invasive evidence of significant increase in ventricular filling pressures or decreased cardiac output. Exclusion Criteria: - Non interpretable lung ultrasound imaging or false positive findings (chronic lung interstitial disease, pneumonia, large pleural effusion). - Lack of willing to provide informed consent - Life expectancy lesser than 6 months - Surgically correctable cause of heart failure (aortic stenosis, mitral regurgitation, multi-vessel coronary artery disease). - Chronic kidney injury with an estimated or measured creatinine clearance rate lower than 15ml/min/1.73m2. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cardiología "Ignacio Chavez" | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cardiologia Ignacio Chavez |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with the composite outcome of hospital readmission + mortality. | Hospital readmission: urgent hospital non scheduled visit and stay of more than 24 hours, requiring medical interventions. Mortality: patient's death. | 6 months. | |
Primary | Number of patients with the composite outcome of hospital readmission + mortality + urgent visits for worsening HF | Hospital readmission: urgent hospital non scheduled visit and stay of more than 24 hours, requiring medical interventions. Mortality: patient's death. Urgent visits for worsening HF: non-scheduled visit to day care or ED that prompted increased oral / IV therapy, less than 24 hours stay. | 6 months | |
Secondary | Quality of life measured by kansas city cardiomyopathy questionnaire (KCCQ) | Quality of life at 6 months assessed by KCCQ | 6 months | |
Secondary | NTproBNP concentrations | NTproBNP concentrations and change by last visit | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
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
|