Actively Recruiting

Age: 60Years - 74Years
FEMALE
NCT06803849

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

Led by National Medical Research Center for Therapy and Preventive Medicine · Updated on 2025-01-31

100

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 60Years - 74Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 60-74 years
  • Diagnosed heart failure with preserved ejection fraction using HFA-PEFF algorithm
  • History of pregnancy lasting at least 20 weeks
  • Willing and legally able to sign informed consent
Not Eligible

You will not qualify if you...

  • History of ejection fraction less than 50% diagnosed by echocardiography
  • Diagnosed cognitive impairment or dementia
  • Current state of cardiovascular disease decompensation
  • Exacerbation of comorbidities
  • Presence of chronic diseases affecting study results, including unstable or severe ischemic heart disease, previous stroke, severe valvular heart diseases, cardiomyopathy, myocarditis, uncontrolled asthma or COPD, terminal kidney disease requiring dialysis
  • Implanted pacemaker or cardiac device such as resynchronisation device or defibrillator
  • Active cancer or history of chemotherapy or radiation therapy to the chest area

AI-Screening

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Trial Site Locations

Total: 1 location

1

Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation

Moscow, Russia, 101990

Actively Recruiting

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Research Team

V

Vasilisa Kosulina, MD

CONTACT

O

Olga Dzhioeva, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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