Heart Failure With Preserved Ejection FractionNCT05095688
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF
An observational study of Heart Failure With Preserved Ejection Fraction and Arterial Stiffness, 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 to 99 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Arterial Stiffness, Lipid Disorder
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2020to 31 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 to 99 years
- 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; 3/Other causes of shortness of breath, such as severe pulmonary disease or severe chronic obstructive pulmonary disease;
- 4.Primary pulmonary hypertension; 5.Severe valvular disease of the left heart; 6.Chronically bedridden or incapacitated; 7.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, 400000
Dongying Zhang, doctor, +8613608398395, zdy.chris@qq.com
About this study
Official title: Relationship Between Adipose Tissue Distribution and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction(HFpEF)
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 lipids distribution and arterial stiffness in HFpEF patients.
Read the detailed description
Before the 21st century, Heart failure with preserved ejection fraction (HFpEF) was considered as a disease with simple diastolic dysfunction, but after the 21st century, 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. Other 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 lipids distribution and arterial stiffness in HFpEF patients.
- Medical subject headings
- Lipid Metabolism Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
The baPWV(cm/s) of HFpEF patients
Measured: 1 day after admission
adipose tissue distribution
The visceral fat area(cm^2) in HFpEF patients
Measured: 1 day after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start21 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 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
- Cross-sectional
- Enrolment
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095688
- Sponsor's protocol ID
- 2020-09-19
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2020
- Last updated
- 27 Oct 2021
- 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 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Adipose Tissue Distribution and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction(HFpEF)
- ClinicalTrials.gov ID
- NCT05095688
- Acronym / sponsor ID
- 2020-09-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Oct 2021 (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 lipids distribution and arterial stiffness in HFpEF patients.
Detailed description
Before the 21st century, Heart failure with preserved ejection fraction (HFpEF) was considered as a disease with simple diastolic dysfunction, but after the 21st century, 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. Other 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 lipids distribution and arterial stiffness in HFpEF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- 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 (3 listed)
- LVEF less than 45% at any time;
- Severe liver failure; 3/Other causes of shortness of breath, such as severe pulmonary disease or severe chronic obstructive pulmonary disease;
- 4.Primary pulmonary hypertension; 5.Severe valvular disease of the left heart; 6.Chronically bedridden or incapacitated; 7.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: 1 day after admission
The baPWV(cm/s) of HFpEF patients
adipose tissue distribution
Time frame: 1 day after admission
The visceral fat area(cm^2) in HFpEF patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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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.
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 and Arterial Stiffness, 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 3 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 27 Oct 2021. 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: 1 day after 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 27 Oct 2021.