Heart FailureCLUSTER-HFNCT03613779
CLUSTER-HF: Lung Ultrasound Guided Therapy in Heart Failure
A study testing LUS-guided therapy in people with Heart Failure, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- LUS-guided therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteMexico
- Study dates
- 10 Apr 2018to 7 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cardiología "Ignacio Chavez"
Mexico City, 14030
About this study
Official title: Efficacy of Lung Ultrasound Guided Therapy to Prevent Rehospitalizations in Heart Failure (CLUSTER-HF): a Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Heart Failure
- Being tested
- LUS-guided therapy, Standard of Care
- Keywords
- Lung ultrasound, Heart failure, Management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUS-guided therapyCombination product
Lung ultrasound guided therapy; if pulmonary congestion (more or equal than 3 B-lines), high dose (80-120mg PO/day furosemide) will be prescribed until next follow up re-assessment. If no congestion (less than 3 B-lines), low dose (0-40mg PO/day furosemide) will be prescribed until next follow up re-assessment
Standard of CareOther
Standard of care will be provided.
| Study group | Role | What they receive |
|---|---|---|
| LUS-guided therapy group | Experimental | LUS-guided therapy group. Patients randomly allocated to this arm will receive standard of care + LUS examination accessible to treating physician in every visit. Depending on the results of LUS examination, a low dose or high dose of diuretics will be administered.
A standardized algorithm will be provided to ensure compliance to guideline-recommended medical therapy for heart failure. Receives: Combination Product: LUS-guided therapy; Other: Standard of Care |
| Control group. | Active comparator | Control group. Patients randomly allocated to this arm will receive standard of care + LUS examination blinded to the treating physician in every visit. Diuretic titration will be based on standard practice (physical examination, symptoms and lab results).
A standardized algorithm will be provided to ensure compliance to guideline-recommended medical therapy for heart failure. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months.
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.
Measured: 6 months
Secondary outcomes (2)
Quality of life measured by kansas city cardiomyopathy questionnaire (KCCQ)
Quality of life at 6 months assessed by KCCQ
Measured: 6 months
NTproBNP concentrations
NTproBNP concentrations and change by last visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start10 Apr 2018
- Primary completion6 Dec 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Araiza-Garaygordobil, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Diego Araiza-Garaygordobil, MD, Principal investigator, Instituto Nacional de Cardiología "Ignacio Chavez"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613779
- Sponsor's protocol ID
- PT-18-078
- Acronym
- CLUSTER-HF
- Status last verified
- Dec 2019
- First submitted
- 29 Jul 2018
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lung Ultrasound Guided Therapy to Prevent Rehospitalizations in Heart Failure (CLUSTER-HF): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03613779
- Acronym / sponsor ID
- CLUSTER-HF / PT-18-078
- Conditions
- Heart Failure
- Keywords
- Lung ultrasound, Heart failure, Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUS-guided therapy group | Experimental | Combination Product: LUS-guided therapy, Other: Standard of CareLUS-guided therapy group. Patients randomly allocated to this arm will receive standard of care + LUS examination accessible to treating physician in every visit. Depending on the results of LUS examination, a low dose or high dose of diuretics will be administered. A standardized algorithm will be provided to ensure compliance to guideline-recommended medical therapy for heart failure. |
| Control group. | Active comparator | Other: Standard of CareControl group. Patients randomly allocated to this arm will receive standard of care + LUS examination blinded to the treating physician in every visit. Diuretic titration will be based on standard practice (physical examination, symptoms and lab results). A standardized algorithm will be provided to ensure compliance to guideline-recommended medical therapy for heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUS-guided therapyLung ultrasound guided therapy; if pulmonary congestion (more or equal than 3 B-lines), high dose (80-120mg PO/day furosemide) will be prescribed until next follow up re-assessment. If no congestion (less than 3 B-lines), low dose (0-40mg PO/day furosemide) will be prescribed until next follow up re-assessment | Combination product | LUS-guided therapy group |
| Standard of CareStandard of care will be provided. | Other | Control group., LUS-guided therapy group |
Primary outcome
Number of patients with the composite outcome of hospital readmission + mortality.
Time frame: 6 months.
Hospital readmission: urgent hospital non scheduled visit and stay of more than 24 hours, requiring medical interventions. Mortality: patient's death.
Number of patients with the composite outcome of hospital readmission + mortality + urgent visits for worsening HF
Time frame: 6 months
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.
2 secondary outcomes
Quality of life measured by kansas city cardiomyopathy questionnaire (KCCQ)
Time frame: 6 months
NTproBNP concentrations
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Araiza-Garaygordobil, MD principal investigator
Instituto Nacional de Cardiología "Ignacio Chavez"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUS-guided therapy in people with Heart Failure, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with the composite outcome of hospital readmission + mortality. (time frame: 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.