Heart FailureEVOLUTIONNCT05747820
Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure
An observational study of Heart Failure and Heart Decompensation, run by Corteria Pharmaceuticals at 4 sites in 2 countries.
Trial summary
This observational study is conducted to assess the evolution of multiple markers of congestion over 4 weeks after a worsening heart failure (WHF) event treated in an outpatient unit Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Heart Decompensation
- What is being tested?
- Observational study
- How many people
- 42 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Sep 2022to 27 Apr 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 40 adult male and female patients with a diagnosis of HFrEF (EF<40%) and HFmrEF (EF >40 < 50%) who had a hospital admission for HF within 1 to12 months prior to screening and developed worsening symptoms of HF during the week prior to presentation to an outpatient clinic.
Who may be able to join
- Male or female patients ≥ 18 and < 80 years of age.
- Previous documented hospital admission for HF between 12 months and 1 month prior to Screening.
- Ambulatory patients with a diagnosis of stable NYHA class II - III HF with left ventricular ejection fraction <50%, who experience a worsening of heart failure (WHF), with worsening signs and/or symptoms of heart failure requiring institution or up titration of loop diuretic therapy, in the week preceding their visit to the outpatient HF clinic and with at the time of Screening:
- Dyspnea and at least one symptom of congestion (rales, orthopnea, peripheral oedema)
- Imaging confirmation of congestion as defined by either pulmonary congestion on chest X-ray or at least 2 B-lines by lung ultrasound.
- Stable oral doses of ACEi, ARB or ARNi, beta-blocker, mineralocorticoid antagonist (MRA), and SGLT2i for > 1 month prior to screening.
Show all 11Show fewer
- An increase in the prescribed oral loop diuretic dose up to 120 mg daily furosemide or equivalent*for the treatment of the WHF event.
- Biomarker profile suggestive of significant HF inclusive of NT-proBNP ≥1500 pg/ml, and elevated TnT from 15 ng/L (0.015 mcg/L) to 150 ng/L (0.15 mcg/L) or equivalent TnI using ultrasensitive assay.
- Mild to moderate renal impairment (eGFR by the simplified MDRD formula of >30 and <60 ml/min/1.73 m2).
- Written informed consent to participate in the study.
- Ability to comply with all study requirements, without major morbidities compromising the patient's ability to participate and understand the study for 90 days.
Who cannot join
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic steroid therapy.
- Myocardial infarction, unstable angina, ICD or CRT implantation, or cardiac surgery, including percutaneous transluminal coronary intervention, within past 3 months.
- History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.
- Significant uncontrolled arrythmia such as atrial fibrillation with a persistent heart rate > 120 beast/minute, any bradyarrhythmia with a persistent heart rate < 50 beats/min, sustained supraventricular tachycardia, any evidence of tri-fascicular block by ECG.
- Sustained ventricular arrhythmia with syncopal episodes within past 3 months that is untreated.
- Presence of any hemodynamically moderate or severe valvular stenosis or regurgitation, except for moderate mitral or tricuspid regurgitation secondary to left ventricular dilatation. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract.
Show all 23Show fewer
- Stroke or TIA within the past 3 months.
- Primary or alcoholic liver disease considered to be life threatening.
- Any episode of symptomatic hypotension within 3 months prior to screening.
- Coagulation or bleeding disorder.
- Systolic blood pressure < 100 mmHg or >180 mmHg.
- Serum sodium > 146 mEq/L (146 mmol/L) or <135 mEq/L
- Serum potassium > 5.2 mEq/L (5.2 mmol/L) or < 3.5 mEq/L (3.5 mmol/ L).
- Ultrafiltration or dialysis within 3 months prior to Screening.
- Hypersensitivity to furosemide.
- History or presence of any other diseases (i.e. including malignancies) with a life expectancy of < 3 months.
- Participation in any CHF trial or any investigational drug or device study within the 30 days prior to Screening.
- History of noncompliance to medical regimens and patients who are considered potentially unreliable.
- Pregnant or nursing (lactating) women.
- Active infection based on abnormal temperature and/or elevated WBC count.
- Any evidence of COVID -19 infection
- Hemoglobin <8 g/L or receipt of blood transfusion within 3 months prior to Screening.
- Contraindication to the use of the wrist-worn telemetry device: skin problem or wound in the wrist area, inclusive of tattoos.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Armenia2 sites
Institute of Cardiology Levon Hovhannisyan
Yerevan, 0014
Erebuni Medical Center
Yerevan, 0087
Bosnia and Herzegovina2 sites
Health Institution Medico Laser, Cardiology ward
Banja Luka, 78000
Universty Clinical Hospital Mostar, Clinic for Internal diseases with dyalisis center, Clinical ward for cardiology
Mostar, 88000
About this study
Official title: Observational Study for Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure (EVOLUTION)
This observational study is conducted to assess the evolution of multiple markers of congestion over 4 weeks after a worsening heart failure (WHF) event treated in an outpatient unit
Read the detailed description
This is a multicenter, non-randomized, observational study designed to assess the evolution of multiple markers (physical, echocardiographic, and biomarkers) of congestion in 40 patients with chronic heart failure (CHF) treated over 4 weeks with 40 to 120 mg daily oral furosemide after an event of WHF treated in an outpatient unit. Patients at selected centers may participate in a telemetry ancillary study, in which real-time, continuous, non-invasive measurements of physiologic parameters of heart failure will be obtained through use of a wearable medical telemetry device.
Approximately 40 patients with CHF with reduced or mildly reduced left ventricular ejection fraction (EF < 50%) who had an admission for WHF in the preceding 1-12 months and who develop symptoms of WHF over the week before presentation to an outpatient clinic will be enrolled. Patients will attend five outpatient visits over the course of 4 weeks.
At each visit, the patient's vital signs will be measured, clinical assessments (NYHA class, jugular vein distension, peripheral edema score, pulmonary rales) will be performed, and blood samples for central assays will be obtained. Detailed echocardiographic examination will be performed prior to enrolment in the first visit and at Visit 5.
Biomarkers related to cardiac and renal function will be measured in blood and urine samples at each visit.
- Conditions
- Heart Failure, Heart Decompensation
- Being tested
- Observational study
- Keywords
- Worsening Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study designed to assess the evolution of multiple markers of congestion over 4 weeks after a WHF event treated in an outpatient unit
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in E/e' ratio
Change in E/e' ratio, measured on echocardiography
Measured: Screening (Visit 1) and week 4 (beginning of Visit 5).
Changes in Left Ventricular End-Diastolic Diameter (LVEDD)
Changes in LVEDD measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Left Ventricular End-Systolic Diameter (LVESD)
Changes in LVESD measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Left Ventricular End-Diastolic Volume (LVEDV)
Changes in LVEDV measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Left Ventricular End-Systolic Volume (LVESV)
Changes in LVESV measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Left Ventricular Ejection Fraction (LVEF)
Changes in LVEF measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in mitral E-velocity
Changes in mitral E-velocity measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in mitral A-velocity
Changes in mitral A-velocity measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in E' velocity
Changes in E' velocity measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Right Ventricular Systolic Pressure (RVSP)
Changes in RVSP measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Tricuspid Annular Pulmonary Systolic Excursion (TAPSE)
Changes in TAPSE measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in S' velocity
Changes in S' velocity measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Inferior Vena Cava (IVC) diameter
Changes in IVC (minimum and maximum) measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Left Atrium (LA) surface
Changes in LA surface measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in Right Atrium (RA) surface
Changes in RA surface measured on echocardiography from screening to Week 4
Measured: From screening to 4 weeks
Changes in patient-reported dyspnea
Weekly changes in patient-reported dyspnea
Measured: From screening to 4 weeks
Changes in clinically-assessed jugular venous pulse
Weekly changes in clinically-assessed jugular venous pulse
Measured: From screening to 4 weeks
Changes in clinically-assessed peripheral edema
Weekly changes in peripheral edema
Measured: From screening to 4 weeks
Changes in estimated Glomerular Filtration Rate (eGFR)
Changes in eGFR between screening, Week 2 and Week 4 visit.
Measured: From screening to 4 weeks
Changes in serum creatinine
Changes in serum creatinine between screening, Week 2 and Week 4 visit.
Measured: From screening to 4 weeks
Changes in NT-proBNP
Changes in NTproBNP between screening, Week 2 and Week 4 visit.
Measured: From screening to 4 weeks
Changes in high sensitivity Troponin T (HsTnT)
Changes in HsTnT between screening, Week 2 and Week 4 visit.
Measured: From screening to 4 weeks
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12
Changes in KCCQ-12 inclusive of total symptoms score and sub scores from screening to Week 4
Measured: From screening to 4 weeks
Weekly changes in telemetered parameters in patients wearing the wrist-worn device (Philips Health Band)
Weekly changes in activity in those patients wearing the wrist-worn device (Philips Health Band)
Measured: From screening to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start28 Sep 2022
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corteria Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Mebazaa, MD, Principal investigator, Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot, Inserm 942
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747820
- Sponsor's protocol ID
- CHF202102
- Acronym
- EVOLUTION
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure (EVOLUTION)
- ClinicalTrials.gov ID
- NCT05747820
- Acronym / sponsor ID
- EVOLUTION / CHF202102
- Conditions
- Heart Failure, Heart Decompensation
- Keywords
- Worsening Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Corteria PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 28 Feb 2023 (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.
This observational study is conducted to assess the evolution of multiple markers of congestion over 4 weeks after a worsening heart failure (WHF) event treated in an outpatient unit
Detailed description
This is a multicenter, non-randomized, observational study designed to assess the evolution of multiple markers (physical, echocardiographic, and biomarkers) of congestion in 40 patients with chronic heart failure (CHF) treated over 4 weeks with 40 to 120 mg daily oral furosemide after an event of WHF treated in an outpatient unit. Patients at selected centers may participate in a telemetry ancillary study, in which real-time, continuous, non-invasive measurements of physiologic parameters of heart failure will be obtained through use of a wearable medical telemetry device.
Approximately 40 patients with CHF with reduced or mildly reduced left ventricular ejection fraction (EF < 50%) who had an admission for WHF in the preceding 1-12 months and who develop symptoms of WHF over the week before presentation to an outpatient clinic will be enrolled. Patients will attend five outpatient visits over the course of 4 weeks.
At each visit, the patient's vital signs will be measured, clinical assessments (NYHA class, jugular vein distension, peripheral edema score, pulmonary rales) will be performed, and blood samples for central assays will be obtained. Detailed echocardiographic examination will be performed prior to enrolment in the first visit and at Visit 5.
Biomarkers related to cardiac and renal function will be measured in blood and urine samples at each visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 40 adult male and female patients with a diagnosis of HFrEF (EF<40%) and HFmrEF (EF >40 < 50%) who had a hospital admission for HF within 1 to12 months prior to screening and developed worsening symptoms of HF during the week prior to presentation to an outpatient clinic.
Key inclusion criteria (11 listed)
- Male or female patients ≥ 18 and < 80 years of age.
- Previous documented hospital admission for HF between 12 months and 1 month prior to Screening.
- Ambulatory patients with a diagnosis of stable NYHA class II - III HF with left ventricular ejection fraction <50%, who experience a worsening of heart failure (WHF), with worsening signs and/or symptoms of heart failure requiring institution or up titration of loop diuretic therapy, in the week preceding their visit to the outpatient HF clinic and with at the time of Screening:
- Stable oral doses of ACEi, ARB or ARNi, beta-blocker, mineralocorticoid antagonist (MRA), and SGLT2i for > 1 month prior to screening.
- An increase in the prescribed oral loop diuretic dose up to 120 mg daily furosemide or equivalent*for the treatment of the WHF event.
Key exclusion criteria (23 listed)
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1< 1 liter or need for chronic steroid therapy.
- Myocardial infarction, unstable angina, ICD or CRT implantation, or cardiac surgery, including percutaneous transluminal coronary intervention, within past 3 months.
- History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.
- Significant uncontrolled arrythmia such as atrial fibrillation with a persistent heart rate > 120 beast/minute, any bradyarrhythmia with a persistent heart rate < 50 beats/min, sustained supraventricular tachycardia, any evidence of tri-fascicular block by ECG.
- Sustained ventricular arrhythmia with syncopal episodes within past 3 months that is untreated.
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 |
|---|---|---|
| Observational studyThis is an observational study designed to assess the evolution of multiple markers of congestion over 4 weeks after a WHF event treated in an outpatient unit | Other | – |
Primary outcome
Change in E/e' ratio
Time frame: Screening (Visit 1) and week 4 (beginning of Visit 5).
Change in E/e' ratio, measured on echocardiography
Changes in Left Ventricular End-Diastolic Diameter (LVEDD)
Time frame: From screening to 4 weeks
Changes in LVEDD measured on echocardiography from screening to Week 4
Changes in Left Ventricular End-Systolic Diameter (LVESD)
Time frame: From screening to 4 weeks
Changes in LVESD measured on echocardiography from screening to Week 4
Changes in Left Ventricular End-Diastolic Volume (LVEDV)
Time frame: From screening to 4 weeks
Changes in LVEDV measured on echocardiography from screening to Week 4
Changes in Left Ventricular End-Systolic Volume (LVESV)
Time frame: From screening to 4 weeks
Changes in LVESV measured on echocardiography from screening to Week 4
Changes in Left Ventricular Ejection Fraction (LVEF)
Time frame: From screening to 4 weeks
Changes in LVEF measured on echocardiography from screening to Week 4
Changes in mitral E-velocity
Time frame: From screening to 4 weeks
Changes in mitral E-velocity measured on echocardiography from screening to Week 4
Changes in mitral A-velocity
Time frame: From screening to 4 weeks
Changes in mitral A-velocity measured on echocardiography from screening to Week 4
Changes in E' velocity
Time frame: From screening to 4 weeks
Changes in E' velocity measured on echocardiography from screening to Week 4
Changes in Right Ventricular Systolic Pressure (RVSP)
Time frame: From screening to 4 weeks
Changes in RVSP measured on echocardiography from screening to Week 4
Changes in Tricuspid Annular Pulmonary Systolic Excursion (TAPSE)
Time frame: From screening to 4 weeks
Changes in TAPSE measured on echocardiography from screening to Week 4
Changes in S' velocity
Time frame: From screening to 4 weeks
Changes in S' velocity measured on echocardiography from screening to Week 4
Changes in Inferior Vena Cava (IVC) diameter
Time frame: From screening to 4 weeks
Changes in IVC (minimum and maximum) measured on echocardiography from screening to Week 4
Changes in Left Atrium (LA) surface
Time frame: From screening to 4 weeks
Changes in LA surface measured on echocardiography from screening to Week 4
Changes in Right Atrium (RA) surface
Time frame: From screening to 4 weeks
Changes in RA surface measured on echocardiography from screening to Week 4
Changes in patient-reported dyspnea
Time frame: From screening to 4 weeks
Weekly changes in patient-reported dyspnea
Changes in clinically-assessed jugular venous pulse
Time frame: From screening to 4 weeks
Weekly changes in clinically-assessed jugular venous pulse
Changes in clinically-assessed peripheral edema
Time frame: From screening to 4 weeks
Weekly changes in peripheral edema
Changes in estimated Glomerular Filtration Rate (eGFR)
Time frame: From screening to 4 weeks
Changes in eGFR between screening, Week 2 and Week 4 visit.
Changes in serum creatinine
Time frame: From screening to 4 weeks
Changes in serum creatinine between screening, Week 2 and Week 4 visit.
Changes in NT-proBNP
Time frame: From screening to 4 weeks
Changes in NTproBNP between screening, Week 2 and Week 4 visit.
Changes in high sensitivity Troponin T (HsTnT)
Time frame: From screening to 4 weeks
Changes in HsTnT between screening, Week 2 and Week 4 visit.
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12
Time frame: From screening to 4 weeks
Changes in KCCQ-12 inclusive of total symptoms score and sub scores from screening to Week 4
Weekly changes in telemetered parameters in patients wearing the wrist-worn device (Philips Health Band)
Time frame: From screening to 4 weeks
Weekly changes in activity in those patients wearing the wrist-worn device (Philips Health Band)
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 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Alexandre Mebazaa, MD principal investigator
Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot, Inserm 942
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Decompensation, run by Corteria Pharmaceuticals at 4 sites in 2 countries.
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 11 inclusion and 23 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Armenia, Bosnia and Herzegovina. 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?
Change in E/e' ratio (time frame: Screening (Visit 1) and week 4 (beginning of Visit 5).). The study lists 24 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 13 Feb 2024.