CompletedNot Applicable

Multiparametric Assessment of Cardiac Congestion in Outpatient Worsening Heart Failure

Armenia, Bosnia and Herzegovina42 participantsStarted 2022-09-28

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in E/e' ratio

Timeframe: Screening (Visit 1) and week 4 (beginning of Visit 5).

Changes in Left Ventricular End-Diastolic Diameter (LVEDD)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular End-Systolic Diameter (LVESD)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular End-Diastolic Volume (LVEDV)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular End-Systolic Volume (LVESV)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular Ejection Fraction (LVEF)

Timeframe: From screening to 4 weeks

Changes in mitral E-velocity

Timeframe: From screening to 4 weeks

Trial details

NCT IDNCT05747820

SponsorCorteria Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04-27

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

Change in E/e' ratio

Timeframe: Screening (Visit 1) and week 4 (beginning of Visit 5).

Changes in Left Ventricular End-Diastolic Diameter (LVEDD)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular End-Systolic Diameter (LVESD)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular End-Diastolic Volume (LVEDV)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular End-Systolic Volume (LVESV)

Timeframe: From screening to 4 weeks

Changes in Left Ventricular Ejection Fraction (LVEF)

Timeframe: From screening to 4 weeks

Changes in mitral E-velocity

Timeframe: From screening to 4 weeks