Predictors of Poor Prognosis in HFpEF | NCT06844032

Studies
Predictors of Poor Prognosis in HFpEF

NCT06844032

Sponsor

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Status

Recruiting

Last Update Posted

Apr 17, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

HFpEF

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Feb 19, 2025

First Submission Date that Met QC Criteria

Feb 19, 2025

First Posted Date

Feb 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2026

Last Update Posted Date

Apr 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Measure	Description	Time Frame
Hospitalization for exacerbation of HF		From enrollment to August 2026
All-cause mortality		From enrollment to August 2026

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Artem G Ovchinnikov, MD, PhD, DSc	Contact	+74954146612		artcardio@mail.ru

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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	Recruiting	Moscow		121552	Russia

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006984	Hypertrophy