Heart FailureKCCQ-WHFNCT07552142
Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening
An observational study of Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
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… 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?
- Serial KCCQ assessments delivered via chatbot
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2025to 1 Apr 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: 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.
Who may be able to join
- Established diagnosis of chronic HF with reduced, mildly reduced, or preserved ejection fraction, NYHA II-III
- History of heart failure (HF) hospitalization within the last 6 months before enrollment, defined as the presence of dyspnea, elevated NT-proBNP ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF), and 2 of the following: i. Rales on chest auscultation or signs of congestion on X-ray/CT scan; ii. Peripheral Oedema; iii. Loop diuretics IV at admission
- Free of signs and symptoms of congestion, defined as JVP of <8 cm, with no orthopnea, pulmonary rales, and with trace peripheral edema or no edema.
- Stable doses of oral loop diuretics, if prescribed
- Ability to provide informed consent
Who cannot join
- Acute coronary syndrome, cardiac surgery, pulmonary embolism, cerebrovascular accident, ablation of atrial flutter/fibrillation, valve repair/replacement, implanted cardioverter defibrillator or urgent PCI within the last 3 months
- Planned interventions, including major cardiac surgery (coronary artery bypass grafting, valve repair/replacement, ventricular assist device, cardiac transplantation), coronary revascularization, implantation of a cardiac device or ablation of atrial flutter/fibrillation during the study
- Previous cardiac transplantation and candidates for heart transplantation
- Complex congenital heart disease
- Heart failure due to active myocarditis, pericardial constriction, known hypertrophic cardiomyopathy or cardiac amyloidosis, or uncorrected severe valvular heart disease
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
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- Cirrhosis, chronic active hepatitis, or other severe hepatic disease
- Significant drug or alcohol abuse during the last year
- Hemodialysis
- Infective endocarditis
- Any active cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Svetlana Rachina contact
Russia1 site, 1 recruiting
- Recruiting
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Non-US/Non-Canadian
Anastasia Shchendrygina, +79262309207, a.shchendrygina@gmail.com
Svetlana Rachina, rachina_s_a@staff.sechenov.ru
About this study
Official title: Patient-Reported Health Status Assessment Using the Kansas City Cardiomyopathy Questionnaire for Early Detection of Heart Failure Worsening
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Serial KCCQ assessments delivered via chatbot
- Keywords
- Kansas City Cardiomyopathy Questionnaire, Heart failure, worsening heart failure, monitoring, Cardiovascular Diseases, Heart Diseases, Congestion
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial KCCQ assessments delivered via chatbotOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with heart failure who have been hospitalized for heart failure within the past six months | Not described Receives: Other: Serial KCCQ assessments delivered via chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients who consent and enrol in the study
Recruitment rate
Measured: 6 and 12 months
Median time to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) delivered via chatbot
Measured: Baseline assesment
Proportion of those who stop the study
Dropout rate
Measured: 6 and 12 months
Proportion of completed KCCQ relative to those scheduled
Adherence to the protocol
Measured: 6 and 12 months
The mean rank of patient satisfaction with the intervention assessed by a survey
Acceptability
Measured: 6 and 12 months
Secondary outcomes (18)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3, 6 and 12 months
The regression coefficient (β) relating the change in KCCQ-СSS to the change in the 6-MW distance
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
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
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia Shchendrygina, I.M. Sechenov First Moscow State Medical University
- Investigators
- Anastasia Shchendrygina, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552142
- Sponsor's protocol ID
- 10-25
- Acronym
- KCCQ-WHF
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Health Status Assessment Using the Kansas City Cardiomyopathy Questionnaire for Early Detection of Heart Failure Worsening
- ClinicalTrials.gov ID
- NCT07552142
- Acronym / sponsor ID
- KCCQ-WHF / 10-25
- Conditions
- Heart Failure
- Keywords
- Kansas City Cardiomyopathy Questionnaire, Heart failure, worsening heart failure, monitoring, Cardiovascular Diseases, Heart Diseases, Congestion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 27 Apr 2026 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure who have been hospitalized for heart failure within the past six months | – | Other: Serial KCCQ assessments delivered via chatbot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Established diagnosis of chronic HF with reduced, mildly reduced, or preserved ejection fraction, NYHA II-III
- History of heart failure (HF) hospitalization within the last 6 months before enrollment, defined as the presence of dyspnea, elevated NT-proBNP ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF), and 2 of the following: i. Rales on chest auscultation or signs of congestion on X-ray/CT scan; ii. Peripheral Oedema; iii. Loop diuretics IV at admission
- Free of signs and symptoms of congestion, defined as JVP of <8 cm, with no orthopnea, pulmonary rales, and with trace peripheral edema or no edema.
- Stable doses of oral loop diuretics, if prescribed
- Ability to provide informed consent
Key exclusion criteria (11 listed)
- Acute coronary syndrome, cardiac surgery, pulmonary embolism, cerebrovascular accident, ablation of atrial flutter/fibrillation, valve repair/replacement, implanted cardioverter defibrillator or urgent PCI within the last 3 months
- Planned interventions, including major cardiac surgery (coronary artery bypass grafting, valve repair/replacement, ventricular assist device, cardiac transplantation), coronary revascularization, implantation of a cardiac device or ablation of atrial flutter/fibrillation during the study
- Previous cardiac transplantation and candidates for heart transplantation
- Complex congenital heart disease
- Heart failure due to active myocarditis, pericardial constriction, known hypertrophic cardiomyopathy or cardiac amyloidosis, or uncorrected severe valvular heart disease
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 |
|---|---|---|
| Serial KCCQ assessments delivered via chatbotEligible 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. | Other | Patients with heart failure who have been hospitalized for heart failure within the past six months |
Primary outcome
Proportion of eligible patients who consent and enrol in the study
Time frame: 6 and 12 months
Recruitment rate
Median time to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) delivered via chatbot
Time frame: Baseline assesment
Proportion of those who stop the study
Time frame: 6 and 12 months
Dropout rate
Proportion of completed KCCQ relative to those scheduled
Time frame: 6 and 12 months
Adherence to the protocol
The mean rank of patient satisfaction with the intervention assessed by a survey
Time frame: 6 and 12 months
Acceptability
18 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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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.
Svetlana Rachina contact
Anastasia Shchendrygina principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Shchendrygina (+79262309207, a.shchendrygina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible patients who consent and enrol in the study (time frame: 6 and 12 months). The study lists 5 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 27 Apr 2026.