An observational study in Heart Failure, sponsored by I.M. Sechenov First Moscow State Medical University. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by I.M. Sechenov First Moscow State Medical University · Observational
This observational feasibility study aims to assess (i) how practical and acceptable repeated KCCQ assessments are; (ii) the connection between changes over time in KCCQ scores and signs of congestion; and (iii) clinical outcomes, including worsening heart failure events or cardiovascular death (CVD), and the time between 5- and 10-point KCCQ changes and clinical events.
The course of heart failure (HF) is characterized by episodes of worsening HF (WHF). These episodes increase the risk of hospitalization and death. Currently, reliable instruments for early identification of WHF are underdeveloped. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific, self-administered instrument designed to assess patient status. KCCQ allows detection of changes in clinical status in HF patients within a 14-day recall period and has the potential for early detection of WHF.
The study is an investigator-initiated, prospective, observational feasibility study aims to assess the (i) feasibility and acceptability of serial KCCQ assessment; (ii) the relationship between temporal changes in KCCQ scores and markers of congestion, as well as (iii) clinical outcome, a composite of worsening heart failure events or cardiovascular death (CVD), and the time from 5- and 10-point KCCQ changes to clinical events.
The study population will include 120 patients aged 18 years and above who meet the criteria. Eligible patients will undergo serial KCCQ assessments every 2 weeks for 12 months. Transthoracic echocardiography (TTE), lung ultrasound (LUS), 6-minute walk test (6MWT), and blood sampling will be performed at baseline, 3, 6, and 12 months. Outcomes will be collected at 6 and 12 months.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men and women aged ≥ 18 years with an established diagnosis of heart falure who were admitted to the center the last 6 months will be candidates for screening. They will be enrolled if they meet the inclusion criteria and none of the exclusion criteria are present. If hospitalized at the time of screening, the patient will be enrolled in the study after stabilization and when free of signs and symptoms of congestion (defined as jugular venous pressure of \<8 cm, with no pulmonary rales, orthopnea, and with trace peripheral edema or no edema) and is stable on a maintenance dose of oral diuretics for 48 hours.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Serial KCCQ assessments delivered via chatbot
Eligible patients will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 14-day intervals for a duration of 12 months. The KCCQ will be assessed using a chatbot delivered via Telegram Messenger, developed specifically for this study by the research team.
Proportion of eligible patients who consent and enrol in the study
Recruitment rate
Time frame: 6 and 12 months
Median time to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) delivered via chatbot
Time frame: Baseline assesment
Proportion of those who stop the study
Dropout rate
Time frame: 6 and 12 months
Proportion of completed KCCQ relative to those scheduled
Adherence to the protocol
Time frame: 6 and 12 months
The mean rank of patient satisfaction with the intervention assessed by a survey
Acceptability
Time frame: 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-Total Symptoms Score (KCCQ-TSS) to the change in early mitral inflow velocity to early diastolic mitral annular velocity (E/e' ratio) assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in left atrial volume index (LAVI) assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in tricuspid regurgitation (TR) velocity assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in pulmonary capillary wedge pressure (PCWP) assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in inferior vena cava (IVC) assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in total number of B-lines assessed by lung ultrasound at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS and changes in N-terminal pro-B-type Natriuretic Peptide (NTproBNP) at 3,6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS and changes in Cancer Antigen 125 (CA-125) at 3,6 and 12 months.
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-TSS to the change in the 6-Minute Walk (6MW) distance
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ Clinical Summary Score (KCCQ-CSS) to the change in E/e' ratio assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-CSS to the change in LAVI assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-CSS to the change in TR velocity assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-CSS to the change in PCWP assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS to the change in inferior vena cava IVC assessed by echocardiography at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS to the change in total number of B-lines assessed by lung ultrasound at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS and changes in NTproBNP at 3,6 and 12 months
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating changes in KCCQ-СSS to changes in CA-125 at 3, 6, and 12 months.
Time frame: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS to the change in the 6-MW distance
Time frame: 3, 6 and 12 months
Temporal changes in KCCQ-TSS to a composite of worsening heart failure (WHF) events and their components
Composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death.
Time frame: 6 and 12 months
Temporal changes in KCCQ-OSS, KCCQ-CSS, and PLS to a composite of WHF events and their components
A composite of WHF events to composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death.
Time frame: 6 and 12 months
Mean time from 5- and 10-point change in KCCQ-TSS to a composite WHF events
Composite of WHF events to composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death
Time frame: 6 and 12 months
Mean time from 5- and 10-point change KCCQ-OSS, KCCQ-CSS, and PLS to a composite of WHF events
A composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death/.
Time frame: 6 and 12 months
Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2027, 24 months after the start.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 24 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
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