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The primary purpose of this study is to evaluate possible association of some heterogeneous circulating biomarkers and anamnestic factors of pregnancy adverse course and outcomes with the prognosis of heart failure with preserved ejection fraction. The study population includes women aged 60-74 years with history of pregnancy with duration at least 20 weeks and diagnosed heart failure with preserved ejection fraction based on algorithm HFA-PEFF.
The following pregnancy complications are assessed on the initial visit: gestational hypertension, preeclampsia, gestation diabetes mellitus and recently introduced as cardiovascular disease risk factors preterm delivery, stillbirth, miscarriage. This information is collected through a questionnaire which additionally includes questions about menopause and the circumstances of its onset. The data about comorbidities, results of laboratory and instrumental tests is collected from medical records. After the interview short physical examination is performed to measure anthropometric data and objective signs of congestion. In addition, medical Research Council Scale survey is conducted to assess the subjective severity of shortness of breath and a six-minute walking test to objectively evaluate the heart failure functional class.
After inclusion in the study blood sampling is performed to measure the concentration of a number of biomarkers which are recognized as prognostically significant in context of heart failure: high-sensitivity troponin I, soluble suppression of tumorigenicity 2 protein, heat shock protein 27, cystatin C. As part of the study echocardiography is also performed with evaluation of left ventricular global longitudinal strain and left atrial strain to assess systolic and diastolic myocardium function.
12 months after the initial visit, participants are contacted by telephone. The data about newly diagnosed chronic non-communicable diseases, emergency hospitalization for any cause and major adverse cardiovascular events is collected. If there is no response from the research participant, the cause, including possible hospitalization or death, is determined by telephone contact with the participant's trusted person.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with anamnestic factors of pregnancy adverse course and outcomes | |||
| Patients without anamnestic factors of pregnancy adverse course and outcomes |
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| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint made up of emergency hospitalization for any cause, major adverse cardiovascular events and all-cause mortality | Major adverse cardiovascular events include myocardial infarction, stroke, cardiovascular death | From the date of enrollment until the date of the first emergency hospitalization for any cause or date of any major adverse cardiovascular event or all-cause death, whichever came first, assessed up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Newly diagnosed chronic non-communicable disease | Chronic non-communicable diseases include cardiovascular diseases, respiratory system diseases, diabetes mellitus, cancer | From the date of enrollment until the date of diagnosis of any chronic non-communicable disease, whichever came first, assessed up to 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 60-74 years with history of pregnancy with duration at least 20 weeks and diagnosed heart failure with preserved ejection fraction based on algorithm HFA-PEFF
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasilisa Kosulina, MD | Contact | +7-996-981-40-27 | vasilisa.kosulina@mail.ru | |
| Olga Dzhioeva, MD, PhD | Contact | +7-916-614-18-21 | odzhioeva@gnicpm.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation | Recruiting | Moscow | 101990 | Russia |
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Venous blood
|
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| D016640 | Diabetes, Gestational |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| D011248 | Pregnancy Complications |
| D047928 | Premature Birth |
| D050497 | Stillbirth |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D005313 | Fetal Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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