Clinical trial NCT06114498: Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
Official title: Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Obesity, Mild
Decompensated Heart Failure
Keywords: Hearth failure
Decompensated Heart Failure
Heart Failure with Preserved Ejection Fraction
HFpEF
Heat shock protein
Obesity
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Moscow State Clinical Hospital named after V.V. Veresaev
First posted: 2023-11-02
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generic Moscow population

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

All patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental (EchoCG) and/or laboratory criteria.

Exclusion Criteria:

Refusal to sign informed consent to participate in a clinical trial and to process personal data.

Primary outcomes:
measure: Amount of secondary hospitalisations
timeFrame: 6 months
Secondary outcomes:
measure: Amount of hospitalisations with acute coronary syndrome
timeFrame: 6 months
measure: Amount of hospitalisations with stroke
timeFrame: 6 months
measure: Amount of hospitalisations with pulmonary embolism
timeFrame: 6 months
measure: Amount of other cardiovascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow State Clinical Hospital named after V.V. Veresaev
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Therapy and Preventive Medicine
Study officials:
affiliation: National Medical Research Center for Therapy and Preventive Medicine
name: Yury Timfeev, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Medical Research Center for Therapy and Preventive Medicine
name: Olga Dzhioeva, MD
role: STUDY_DIRECTOR
affiliation: Moscow State Clinical Hospital named after V.V. Veresaev
name: Timofei Vedenikin
role: PRINCIPAL_INVESTIGATOR
References: