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Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction

NCT06803849 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFPEF)

Sponsors & Collaborators

  • National Medical Research Center for Therapy and Preventive Medicine

    lead OTHER_GOV

Eligibility

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

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-12-31
Completion
2026-12-31

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 NCT06803849 on ClinicalTrials.gov