Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure

NCT05747820 | Completed

• 1 other identifier: CHF202102
• Study Type: observational
• Target: 42
• Locations: 2 countries
• Sites: 4

Brief 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

Conditions

Heart Failure; Heart Decompensation

Keywords

Worsening Heart Failure

Outcome Measures

Primary Outcomes (24)

• Change in E/e' ratio

  Change in E/e' ratio, measured on echocardiography

  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

  From screening to 4 weeks

• Changes in Left Ventricular End-Systolic Diameter (LVESD)

  Changes in LVESD measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in Left Ventricular End-Diastolic Volume (LVEDV)

  Changes in LVEDV measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in Left Ventricular End-Systolic Volume (LVESV)

  Changes in LVESV measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in Left Ventricular Ejection Fraction (LVEF)

  Changes in LVEF measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in mitral E-velocity

  Changes in mitral E-velocity measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in mitral A-velocity

  Changes in mitral A-velocity measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in E' velocity

  Changes in E' velocity measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in Right Ventricular Systolic Pressure (RVSP)

  Changes in RVSP measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in Tricuspid Annular Pulmonary Systolic Excursion (TAPSE)

  Changes in TAPSE measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in S' velocity

  Changes in S' velocity measured on echocardiography from screening to Week 4

  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

  From screening to 4 weeks

• Changes in Left Atrium (LA) surface

  Changes in LA surface measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in Right Atrium (RA) surface

  Changes in RA surface measured on echocardiography from screening to Week 4

  From screening to 4 weeks

• Changes in patient-reported dyspnea

  Weekly changes in patient-reported dyspnea

  From screening to 4 weeks

• Changes in clinically-assessed jugular venous pulse

  Weekly changes in clinically-assessed jugular venous pulse

  From screening to 4 weeks

• Changes in clinically-assessed peripheral edema

  Weekly changes in peripheral edema

  From screening to 4 weeks

• Changes in estimated Glomerular Filtration Rate (eGFR)

  Changes in eGFR between screening, Week 2 and Week 4 visit.

  From screening to 4 weeks

• Changes in serum creatinine

  Changes in serum creatinine between screening, Week 2 and Week 4 visit.

  From screening to 4 weeks

• Changes in NT-proBNP

  Changes in NTproBNP between screening, Week 2 and Week 4 visit.

  From screening to 4 weeks

• Changes in high sensitivity Troponin T (HsTnT)

  Changes in HsTnT between screening, Week 2 and Week 4 visit.

  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

  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)

  From screening to 4 weeks

Interventions

Observational study OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Corteria Pharmaceuticals: lead

Study Sites (4)

Institute of Cardiology Levon Hovhannisyan

Yerevan, 0014, Armenia

Location

Erebuni Medical Center

Yerevan, 0087, Armenia

Location

Health Institution Medico Laser, Cardiology ward

Banja Luka, 78000, Bosnia and Herzegovina

Location

Universty Clinical Hospital Mostar, Clinic for Internal diseases with dyalisis center, Clinical ward for cardiology

Mostar, 88000, Bosnia and Herzegovina

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (plasma) and urine samples for central laboratory assessment will be taken at Visits 1, and Visit 5. Sample aliquots will be stored frozen locally until shipped for longer-term storage and analysis. Unused samples will be discarded within 7 years after the study's completion.

MeSH Terms

Conditions

Heart Failure

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Alexandre Mebazaa, MD

  Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot, Inserm 942

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 28, 2023
• Study Start: September 28, 2022
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2); BO (2)