HFpEFNCT06844032
Predictors of Poor Prognosis in HFpEF
An observational study of HFpEF, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.
Trial summary
Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HFpEF
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 31 Jan 2022to 31 Dec 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with HFpEF who underwent meticulous clinical evaluation between 2013 and 2020 at the National Medical Research Centre for Cardiology (Moscow, Russian Federation)
Who may be able to join
- Signed and data informed consent;
- New York Heart Association (NYHA) class II-III heart failure;
- Left ventricular ejection fraction > 50%;
- Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.
Who cannot join
- Evidence of myocardial ischemia during stress echocardiography;
- Significant lesions of the main coronary arteries;
- Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);
- Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;
- Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);
- Primary pulmonary artery hypertension;
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- Significant left-sided structural valve disease;
- Anemia (Hb < 100 g/L);
- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (CKD-EPI);
- Non-cardiac conditions that complicate/exclude participation in the study;
- Exacerbation of heart failure less than 3 months prior to study entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEMICIAN E.I.CHAZOV. of the Ministry of Health of the Russian Federation
Moscow, 121552
Artem Ovchinnikov, MD, PhD, DSc, artcardio@mail.ru
About this study
Official title: Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure With Preserved Ejection Fraction
Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) is a serious condition with an unfavorable prognosis.
The investigators aimed to evaluate in patients with HFpEF:
- the prognostic significance of standard resting hemodynamic parameters compared to key cardiac reserves;
- the prognostic significance of clinical parameters (sex, age, NYHA class, extra-cardiac diseases, therapy);
- the prognostic significance of biological markers of hemodynamic stress and biomarkers of inflammation and fibrosis;
- to identify independent predictors of adverse prognosis of HFpEF.
- Conditions
- HFpEF
- Keywords
- HFpEF, HF, diastolic dysfunction, left ventricle (LV) filling pressures, left ventricular hypertrophy, cardiac reserves, myocardial fibrosis
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with primary outcome | Patients with HFpEF who experienced primary outcome (were hospitalized for HF or died) | |
| without primary outcome | Patients with HFpEF who survived without hospitalization for HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for exacerbation of HF
Measured: From enrollment to August 2026
All-cause mortality
Measured: From enrollment to August 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start31 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEFStudies 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844032
- Sponsor's protocol ID
- AAAA-A18-118022290061-03
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06844032
- Acronym / sponsor ID
- AAAA-A18-118022290061-03
- Conditions
- HFpEF
- Keywords
- HFpEF, HF, diastolic dysfunction, left ventricle (LV) filling pressures, left ventricular hypertrophy, cardiac reserves, myocardial fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian FederationOther government
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Feb 2025 (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.
Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) is a serious condition with an unfavorable prognosis.
The investigators aimed to evaluate in patients with HFpEF:
- the prognostic significance of standard resting hemodynamic parameters compared to key cardiac reserves;
- the prognostic significance of clinical parameters (sex, age, NYHA class, extra-cardiac diseases, therapy);
- the prognostic significance of biological markers of hemodynamic stress and biomarkers of inflammation and fibrosis;
- to identify independent predictors of adverse prognosis of HFpEF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with primary outcome | – | –Patients with HFpEF who experienced primary outcome (were hospitalized for HF or died) |
| without primary outcome | – | –Patients with HFpEF who survived without hospitalization for HF |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with HFpEF who underwent meticulous clinical evaluation between 2013 and 2020 at the National Medical Research Centre for Cardiology (Moscow, Russian Federation)
Key inclusion criteria (4 listed)
- Signed and data informed consent;
- New York Heart Association (NYHA) class II-III heart failure;
- Left ventricular ejection fraction > 50%;
- Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.
Key exclusion criteria (11 listed)
- Evidence of myocardial ischemia during stress echocardiography;
- Significant lesions of the main coronary arteries;
- Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);
- Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;
- Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospitalization for exacerbation of HF
Time frame: From enrollment to August 2026
All-cause mortality
Time frame: From enrollment to August 2026
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 17 Apr 2026.
Related trials for HFpEF
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic 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
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
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.
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 HFpEF, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation 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 4 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 17 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 Artem G Ovchinnikov, MD, PhD, DSc (+74954146612, artcardio@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for exacerbation of HF (time frame: From enrollment to August 2026). The study lists 2 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 17 Apr 2026.