Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction (CARPO-HF)
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vasilisa Kosulina, MD
- Phone Number: +7-996-981-40-27
- Email: vasilisa.kosulina@mail.ru
Study Contact Backup
- Name: Olga Dzhioeva, MD, PhD
- Phone Number: +7-916-614-18-21
- Email: odzhioeva@gnicpm.ru
Study Locations
-
-
-
Moscow, Russian Federation, 101990
- Recruiting
- Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
-
Contact:
- Olga Dzhioeva, MD, PhD
- Phone Number: +7-916-614-18-21
- Email: odzhioeva@gnicpm.ru
-
Contact:
- Vasilisa Kosulina, MD
- Phone Number: +7-996-981-49-27
- Email: vasilisa.kosulina@mail.ru
-
Principal Investigator:
- Vasilisa Kosulina, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women aged 60-74 years
- Heart failure with preserved ejection fraction (diagnosed by using HFA-PEFF algorithm)
- History of pregnancy with duration at least 20 weeks
- Willing and legally able to sign informed consent
Exclusion Criteria:
- History of ejection fraction less than 50% diagnosed by echocardiography
- Diagnosed cognitive impairment or dementia
- The state of cardiovascular disease decompensation
- Exacerbation of comorbidities
- The presence of chronic diseases that may affect the results of the study: ischemic heart disease (unstable angina, stable effort angina III-IV grade, previous myocardial infarction), previous Ischemic/hemorrhagic stroke, severe valvular heart diseases, cardiomyopathy, myocarditis, uncontrolled bronchial asthma or chronic obstructive pulmonary disease, terminal chronic kidney disease requiring dialysis, implanted pacemaker (including cardiac resynchronisation device, or defibrillator), active cancer, history of chemotherapy or radiation therapy to the chest area
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients with anamnestic factors of pregnancy adverse course and outcomes
|
|
Patients without anamnestic factors of pregnancy adverse course and outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Combined endpoint made up of emergency hospitalization for any cause, major adverse cardiovascular events and all-cause mortality
Time Frame: From the date of enrollment until the date of the first emergency hospitalization for any cause or date of any major adverse cardiovascular event or all-cause death, whichever came first, assessed up to 1 years
|
Major adverse cardiovascular events include myocardial infarction, stroke, cardiovascular death
|
From the date of enrollment until the date of the first emergency hospitalization for any cause or date of any major adverse cardiovascular event or all-cause death, whichever came first, assessed up to 1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Newly diagnosed chronic non-communicable disease
Time Frame: From the date of enrollment until the date of diagnosis of any chronic non-communicable disease, whichever came first, assessed up to 1 years
|
Chronic non-communicable diseases include cardiovascular diseases, respiratory system diseases, diabetes mellitus, cancer
|
From the date of enrollment until the date of diagnosis of any chronic non-communicable disease, whichever came first, assessed up to 1 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-07/24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.