Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06338943 |
| Other study ID # |
02-02/24 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 18, 2024 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
March 2024 |
| Source |
National Medical Research Center for Therapy and Preventive Medicine |
| Contact |
Max Shperling, MD |
| Phone |
+79118170034 |
| Email |
MaxCardio[@]yandex.ru |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
