Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction

NCT ID: NCT06338943

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2025-01-31

Brief Summary

Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women.

The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy.

Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?

Objectives

1. To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF.

2. To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF.

3. To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.

4. To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.

Study population - 45-60 year-old women with the history of pregnancy (>20 weeks) in the absence of low left ventricle ejection fraction (<50%)

Primary endpoint: The prevalence of HFpEF in patients with the history of APOs.

Detailed Description

Heart failure (HF) occupies a special place in the structure of cardiological pathology. This is largely due to the active modernization of approaches to the diagnosis of HF - every year the possibilities of cardiac imaging increase significantly, which leads to dynamic changes in the criteria for diagnosis. To the greatest extent, these changes affect heart failure with a preserved ejection fraction (HFpEF; left ventricular ejection fraction ≥ 50%), the importance of which is steadily growing with increasing life expectancy, obesity and cardiometabolic disorders. If in the recent past, HF was perceived not as independent disease, which is a complication of the underlying cardiac pathology, today, due to the increasing detectability of HFpEF, the latter can be considered as a separate multifactorial disease. Patients with HFpEF make up about half of the population of patients with HF, which, together with difficulties in understanding the pathophysiological mechanisms of the disease, is a significant problem for clinical practice.

Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. This area of scientific activity has become especially popular in recent years in both world and domestic cardiology. The leading causes of the development of HFpEF are old age, obesity, coronary heart disease and pulmonary hypertension. A significant association has also been established with such markers as female gender, diabetes mellitus (DM), chronic kidney disease (CKD), alcohol abuse, arterial hypertension, smoking and others. Important issue now is the study of the association of pregnancy factors and its complications with the development of various forms of HF in both early and long-term periods. It is known that significant changes in a woman's body during pregnancy contribute to the development of important structural and hemodynamic changes in the cardiovascular system, which, in the absence of predisposing adverse factors, are in most cases reversible. Unfortunately, pathology detected during pregnancy is also often a trigger factor for the formation of structural remodeling of the heart and blood vessels, which can lead to the development of HF in the long term after pregnancy.

Despite the presence of large foreign studies reflecting the high incidence of various forms of chronic non-communicable diseases in women with adverse in the gestational period, the relationship of adverse pregnancy outcomes (APOs) with the development of long-term cardiac pathology, in particular, HFpEF, has not been sufficiently studied. Moreover, approaches to the diagnosis of HFpEF vary significantly, there are often no diagnostic protocols in the studies. In such works, a universal approach is more frequently used without dividing patients into phenotypes, depending on age and comorbidity ("one-size-fits-all approach"), which is critically important in assessing such a heterogeneous disease. The above factors make the interpretation of the data and conclusions ambiguous.

To date, the issue of the association of adverse pregnancy factors with the development of HFpEF in the long-term period is unsolved. It is particularly interesting to study the younger phenotype of patients due to the greater detectability of HFpEF in this group of individuals in Russia compared with Western countries. Studying the nature of this relationship will expand understanding of the role of different APOs in the development of structural and functional changes of the heart in a woman's future.

Conditions

Heart Failure Preserved Ejection Fraction; Pregnancy Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patient with the history of pregnancy

Patient with the history of pregnancy (1 or more > 20 weeks)

This group will further be subdivided in a subgroup with HFpEF and a group without HFpEF

Echocardiography

Intervention Type: DIAGNOSTIC_TEST

Echocardiography to diagnose HFpEF

Questionnaire

Intervention Type: OTHER

Questionnaire to determine the presence of adverse pregnancy outcomes history

Interventions

Echocardiography

Echocardiography to diagnose HFpEF

Intervention Type: DIAGNOSTIC_TEST

Questionnaire

Questionnaire to determine the presence of adverse pregnancy outcomes history

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients who administer to the Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine, who are undergoing echocardiography for medical reasons
• Pregnancy >20 weeks in the anamnesis
• Signed informed consent to participate in the study

Exclusion Criteria

• Refusal to sign an informed consent to participate in a clinical trial and to process personal data
• Detection of left ventricle ejection fraction < 50% according to Echocardiography data

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Dzhioeva, MD, PhD

Role: STUDY_DIRECTOR

National Medical Research Center for Therapy and Preventive Medicine

Locations

National Medical Research Center for Therapy and Preventive Medicine

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Max Shperling, MD

Role: CONTACT

MaxCardio@yandex.ru

+79118170034

Olga Dzhioeva, MD, PhD

Role: CONTACT

odzhioeva@gnicpm.ru

+79166141821

Facility Contacts

Olga Dzhioeva, MD, PhD

Role: primary

odzhioeva@gnicpm.ru

+79166141821

Other Identifiers

02-02/24

Identifier Type: -

Identifier Source: org_study_id