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

NCT06338943 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-04-01

No results posted yet for this study

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.

Conditions

  • Heart Failure Preserved Ejection Fraction
  • Pregnancy Complications

Interventions

DIAGNOSTIC_TEST

Echocardiography

Echocardiography to diagnose HFpEF

OTHER

Questionnaire

Questionnaire to determine the presence of adverse pregnancy outcomes history

Sponsors & Collaborators

  • National Medical Research Center for Therapy and Preventive Medicine

    lead OTHER_GOV

Principal Investigators

  • Olga Dzhioeva, MD, PhD · National Medical Research Center for Therapy and Preventive Medicine

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06338943 on ClinicalTrials.gov