Heart Failure With Preserved Ejection FractionNCT04594499
The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
An observational study of Heart Failure With Preserved Ejection Fraction, run by Chongqing Medical University at 1 site in China.
Trial summary
Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients with preserved ejection fraction (HFpEF)
Who may be able to join
- Adult aged >=18years old;
- Diagnosed with HFpEF.
- Diagnostic criteria including:
- left ventricular ejection fraction ≥50%；
- with the symptoms and/or signs of heart failure；
- BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
- at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction
Who cannot join
- LVEF less than 45% at any time;
- Severe liver failure;
- Primary pulmonary hypertension;
- Age <18 years old.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
东营 Zhang, +8613608398395, zdy.chris@qq.com
About this study
Official title: The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction Patients
Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between blood pressure and arterial stiffness in HFpEF patients with different levels of obesity.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) has typical symptoms and signs of heart failure with preserved ejection fraction (LVEF≥50%). Often associated with obesity, hyperlipidemia and other metabolic syndromes. At present, the incidence of HFpEF accounts for about 50% of heart failure, and it is increasing year by year. However, the specific pathogenesis of HFpEF is unknown, and there is a lack of effective diagnosis and treatment methods. A number of studies have shown that obesity is a unique pathophysiological phenotype of individuals with HFpEF, and the activation of inflammatory mediators is extremely prominent in the pathophysiological process of HFpEF. Therefore, we speculate that both obesity and inflammation are related to increased arterial stiffness.
Obesity is a heterogeneous disease. Certain ectopic fats, such as epicardial adipose tissue (EAT), may be related to obesity-related cardiovascular risks. EAT is a kind of visceral fat. Under pathological conditions, it releases factors harmful to the coronary artery and myocardium, and promotes the transition of EAT to a pro-inflammatory and pro-fibrotic phenotype. Brachial ankle pulse wave velocity (baPWV) is an indicator for evaluating arterial stiffness. It is a relatively simple, non-invasive method for detecting vascular compliance and an independent prediction of cardiovascular events in people without cardiovascular disease. Factors can be used to assess the risk of cardiovascular events. However, no relevant research has confirmed that pericardial fat can increase the arterial stiffness of HFpEF.
This study intends to observe the influence of pericardial fat on the arterial stiffness of HFpEF and explore the relationship between pericardial fat thickness and arterial stiffness of HFpEF, in order to assist the clinic in evaluating the vascular state of HFpEF patients faster and better, and to judge the prognosis. At the same time, EAT has the characteristics of fast metabolism, strong organ fat specificity, and simple measurement. It can also be used as a target for drug targeted therapy, opening up a new way for drug therapy of cardiometabolic diseases.
- Keywords
- epicardial fat tissue, arterial stiffness
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
The arterial stiffness of HFpEF patients, for example brachial ankle pulse wave velocity, ardioankle vascular index and so on.
Measured: On admission
Epicardial Fat Tissue
Epicardial Fat Tissue by cardiac color Doppler ultrasound
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- Dongying Zhang, doctor, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594499
- Sponsor's protocol ID
- 2020-10
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction Patients
- ClinicalTrials.gov ID
- NCT04594499
- Acronym / sponsor ID
- 2020-10
- Keywords
- epicardial fat tissue, arterial stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between blood pressure and arterial stiffness in HFpEF patients with different levels of obesity.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) has typical symptoms and signs of heart failure with preserved ejection fraction (LVEF≥50%). Often associated with obesity, hyperlipidemia and other metabolic syndromes. At present, the incidence of HFpEF accounts for about 50% of heart failure, and it is increasing year by year. However, the specific pathogenesis of HFpEF is unknown, and there is a lack of effective diagnosis and treatment methods. A number of studies have shown that obesity is a unique pathophysiological phenotype of individuals with HFpEF, and the activation of inflammatory mediators is extremely prominent in the pathophysiological process of HFpEF. Therefore, we speculate that both obesity and inflammation are related to increased arterial stiffness.
Obesity is a heterogeneous disease. Certain ectopic fats, such as epicardial adipose tissue (EAT), may be related to obesity-related cardiovascular risks. EAT is a kind of visceral fat. Under pathological conditions, it releases factors harmful to the coronary artery and myocardium, and promotes the transition of EAT to a pro-inflammatory and pro-fibrotic phenotype. Brachial ankle pulse wave velocity (baPWV) is an indicator for evaluating arterial stiffness. It is a relatively simple, non-invasive method for detecting vascular compliance and an independent prediction of cardiovascular events in people without cardiovascular disease. Factors can be used to assess the risk of cardiovascular events. However, no relevant research has confirmed that pericardial fat can increase the arterial stiffness of HFpEF.
This study intends to observe the influence of pericardial fat on the arterial stiffness of HFpEF and explore the relationship between pericardial fat thickness and arterial stiffness of HFpEF, in order to assist the clinic in evaluating the vascular state of HFpEF patients faster and better, and to judge the prognosis. At the same time, EAT has the characteristics of fast metabolism, strong organ fat specificity, and simple measurement. It can also be used as a target for drug targeted therapy, opening up a new way for drug therapy of cardiometabolic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with preserved ejection fraction (HFpEF)
Key inclusion criteria (7 listed)
- Adult aged >=18years old;
- Diagnosed with HFpEF.
- left ventricular ejection fraction ≥50%；
- with the symptoms and/or signs of heart failure；
- BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
Key exclusion criteria (4 listed)
- LVEF less than 45% at any time;
- Severe liver failure;
- Primary pulmonary hypertension;
- Age <18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial stiffness
Time frame: On admission
The arterial stiffness of HFpEF patients, for example brachial ankle pulse wave velocity, ardioankle vascular index and so on.
Epicardial Fat Tissue
Time frame: On admission
Epicardial Fat Tissue by cardiac color Doppler ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongying Zhang, doctor study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongying Zhang, doctor (+8613608398395, zdy.chris@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: On admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.