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

NCT06338943 | Recruiting

• 1 other identifier: 02-02/24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure Preserved Ejection Fraction; Pregnancy Complications

Keywords

Heart Failure Preserved Ejection Fraction; Adverse Pregnancy Outcomes; Arterial Hypertension; Gestational Diabetes; Mediation

Outcome Measures

Primary Outcomes (2)

• HFpEF incidence

  Heart Failure with Preserved Ejection Fraction will be assessed with the transthoracic echocardiography based on the criteria of American Heart Association guidelines, where left ventricle ejection fraction \> 50%.

  on enrollment

• APOs incidence

  Adverse pregnancy outcomes will be determined by means of questionnaire

  on enrollment

Study Arms (1)

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

Diagnostic Test: Echocardiography; Other: Questionnaire

Interventions

Echocardiography DIAGNOSTIC_TEST

Echocardiography to diagnose HFpEF

Patient with the history of pregnancy

Questionnaire OTHER

Questionnaire to determine the presence of adverse pregnancy outcomes history

Patient with the history of pregnancy

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Generic Moscow population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Heart Failure, Diastolic; Pregnancy Complications; Hypertension; Diabetes, Gestational; Negotiating

Interventions

Echocardiography; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Communication; Behavior

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Olga Dzhioeva, MD, PhD

  National Medical Research Center for Therapy and Preventive Medicine

  STUDY DIRECTOR

Central Study Contacts

Max Shperling, MD

CONTACT

+79118170034; MaxCardio@yandex.ru

Olga Dzhioeva, MD, PhD

CONTACT

+79166141821; odzhioeva@gnicpm.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: March 18, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)