Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06114498 |
| Other study ID # |
04-05/23 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
November 2023 |
| Source |
National Medical Research Center for Therapy and Preventive Medicine |
| Contact |
Yury Timofeev, phD |
| Phone |
89150104788 |
| Email |
Timofeev_lab[@]mail.ru |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Study Aim is creation of the Hospital Register of patients with heart failure with preserved
ejection fraction (HFpEF) for a comprehensive assessment of the influence of gender
characteristics, clinical and anamnestic factors, body composition, topical characteristics
of congestion, instrumental data and markers of cellular inflammation and stress on immediate
and long-term outcomes in patients with acute decompensated heart failure with preserved
ejection fraction.
During the study it is planned to assess gender, clinical and anamnestic indicators preceding
hospitalization of patients in the hospital; characterize the features of comorbid status in
the studied group of patient; study the features of drug therapy at the prehospital stage and
during hospitalization in the study group of patient; assess adverse hospital outcomes and
outcomes 6 months after hospital discharge and identify factors associated with them; assess
body composition in patients with acute decompensated heart failure with preserved ejection
fraction in obese patients upon admission to the hospital; characterize the severity and
topical characteristics of congestion and compare with the phenotypes of acute decompensation
of heart failure; asess adverse in-hospital outcomes and outcomes 6 months after hospital
discharge and identify factors associated with them; conduct a clinical and instrumental
examination of patients diagnosed with compensated and decompensated HFpEF, verified by
echocardiography at rest, as well as in patients with HFpEF verified after an additional
diastolic stress test with assessment of intracardiac hemodynamic; analyze the serum
concentrations of biochemical markers associated with cellular stress in these groups of
patients, as well as in the control group of apparently healthy people; conduct an analysis
of associations of biomarker levels with clinical characteristics of patients, the presence
of comorbid diseases, including obesity, as well as with data from instrumental examination
methods; assess the diagnostic capabilities of HFpEF, defined by various criteria, based on
the concentration of the new biomarkers The results obtained will allow us to evaluate the
characteristics of the course and outcomes of the disease in Moscow patients, depending on
the phenotype of acute decompensation of HFpEF, hospitalized in the hospital during the study
period. It is expected to identify phenotypes of acute decompensation of HFpEF that affect
the duration of hospitalization and the development of adverse outcomes in the hospital and
long-term period of the disease.
Description:
THE RELEVANCE OF RESEARCH Identifying patients with heart failure with preserved ejection
fraction (HFpEF) represents a significant public health challenge. In a significant
proportion of patients with HFpEF, no specific underlying etiology has been identified, with
the exception of cardiovascular risk factors such as hypertension, obesity, diabetes
mellitus, the presence of atrial fibrillation, and others. Many of these patients are
classified as having hypertension and do not receive the necessary amount of preventive
interventions aimed at reducing hospitalizations and increasing life expectancy. The
incidence of hospitalization for acute decompensated heart failure is increasing, mainly due
to acute HFpEF. It is hypothesized that systemic inflammation resulting from comorbidities
such as obesity, diabetes mellitus, and hypertension is responsible for the pathogenesis of
myocardial structural and functional changes in HFpEF. Therefore, assessment of clinical and
anamnestic factors and their relationship with signs of structural changes, functional
disorders of intracardiac hemodynamics, signs of congestion and systemic inflammation will
help optimize the diagnostic and treatment algorithm for patients with acute decompensation
of HFpEF.
In this context, additional markers such as body composition measures, ultrasound congestion
criteria, and cellular stress-related biomarkers may complement or even surpass traditional
markers in predicting the severity and prognosis of HFpEF.
The creation of a register and analysis of the data entered into it will help improve the
comprehensive diagnosis of decompensated HFpEF
PURPOSE OF THE STUDY:
Creation of a register of patients with HFpEF for a comprehensive assessment of the influence
of gender characteristics, clinical and anamnestic factors, body composition, topical
characteristics of congestion, instrumental data and markers of cellular inflammation and
stress on immediate and long-term outcomes in patients with acute decompensated heart failure
with preserved ejection fraction.
During the study it is planned
1. Assess gender, clinical and anamnestic indicators preceding hospitalization of patients
in the hospital.
2. Characterize the features of comorbid status in the studied group of patients.
3. To study the features of drug therapy at the prehospital stage and during
hospitalization in the study group of patients.
4. Assess adverse hospital outcomes and outcomes 6 months after hospital discharge and
identify factors associated with them.
5. To assess body composition in patients with acute decompensated heart failure with
preserved ejection fraction in obese patients upon admission to the hospital.
6. Characterize the severity and topical characteristics of congestion and compare with the
phenotypes of acute decompensation of heart failure.
7. Assess adverse in-hospital outcomes and outcomes 6 months after hospital discharge and
identify factors associated with them.
8. Conduct a clinical and instrumental examination of patients diagnosed with compensated
and decompensated HFpEF, verified by echocardiography at rest, as well as in patients
with HFpEF verified after an additional diastolic stress test with assessment of
intracardiac hemodynamics.
9. Analyze the serum concentrations of biochemical markers associated with cellular stress
(heat shock proteins) in these groups of patients, as well as in the control group of
apparently healthy people.
10. Conduct an analysis of associations of biomarker levels with clinical characteristics of
patients, the presence of comorbid diseases, including obesity, as well as with data
from instrumental examination methods
11. Assess the diagnostic capabilities of HFpEF, defined by various criteria, based on the
concentration of the new biomarkers studied
STUDY DESIGN:
Descriptive, open-label, observational study, randomization procedure not planned.
STAGES OF RESEARCH:
1. hospital: creating a patient database followed by:
It is planned to create a database, followed by:
- filling out the consent
- creation of a research registration card indicating:
- Gender
- Age;
- Smoking;
- Previous diagnosis of chronic heart failure;
- Hyperthermia;
- Time from the onset of symptoms to hospitalization, days;
- Taking diuretics on an outpatient basis;
- Taking renin-angiotensin aldosterone blockers on an outpatient basis;
- Taking type 2 sodium glucose cotransporter inhibitors on an outpatient basis;
- Taking anticoagulants on an outpatient basis;
- Taking beta blockers on an outpatient basis;
- Reception of mineralocorticoid receptor antagonists) on an outpatient basis;
- Taking non-steroidal anti-inflammatory drugs on an outpatient basis,
- Alcohol abuse,
- Limited mobility
- Arterial hypertension
- Coronary heart disease,
- Chronic obstructive pulmonary disease,
- Body mass index,
- Vaccination,
- Valvular heart defects,
- Diabetes;
- Oncological diseases,
- Chemotherapy,
- Gastrointestinal pathology,
- Chronic kidney disease)
- Chest X-ray;
- Natriuretic peptide on admission;
- B-lines upon admission;
- Therapy with intravenous diuretics;
- Oral diuretic therapy;
- Renin-angiotensin-aldosterone system blockers permanently;
- Type 2 sodium glucose cotransporter inhibitors
- Anticoagulant therapy in the hospital;
- Height;
- Weight;
- Orthopnoea
- Swelling of the neck veins;
- Edema of the lower extremities;
- Hepatomegaly;
- Total water content;
- Total fat content;
- Left ventricular ejection fraction;
- Pulmonary arterial systolic pressure,
- Relative wall thickness;
- Thickness of epicardial fat
- Inferior vena cava, mm
- Collapse of the Inferior vena cava
- Diameter of the renal vein, mm
- Portal vein diameter, mm
- Enzyme immunoassay of heat shock proteins.
- Analysis of routine biochemical parameters.
- Duration of hospitalization, days.
Stage 2 - determining the nearest outcomes - In-hospital outcomes: death with indication of
the cause of death, transfer with aggravation to another department of the hospital,
discharged
Stage 3 - assessment of long-term outcomes after 6 months, which includes:
- creating a phone contact card
- determine vital status (alive/died) by telephone, and for the deceased, determine the
cause of death and date, place of death, for the living - the number of hospitalizations
over the past 6 months.
- identify repeated hospitalizations over the past period.
- entering the received data into the created electronic database in the data register and
conducting statistical analysis
EXPECTED RESULTS The results obtained will allow us to evaluate the characteristics of the
course and outcomes of the disease in Moscow patients, depending on the phenotype of acute
decompensation of HFpEF, hospitalized in the hospital during the study period. When studying
a cohort of patients hospitalized for emergency reasons, it is expected to identify
phenotypes of acute decompensation of HFpEF that affect the duration of hospitalization and
the development of adverse outcomes in the hospital and long-term period of the disease.
The prospects for further use in clinical practice of analysis of circulating levels of heat
shock proteins in combination with other clinical and instrumental methods will be analyzed.
Based on the data obtained, it is planned to develop laboratory and instrumental algorithms
for additional assessment in patients with HFpEF.
