Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF

Sponsor

Chongqing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05095688

Collaborator

(none)

Enrollment

Location

27.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction Arterial Stiffness Lipid Disorder

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

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Relationship Between Adipose Tissue Distribution and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction(HFpEF)

Actual Study Start Date :

Sep 21, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Arterial stiffness [1 day after admission]
The baPWV(cm/s) of HFpEF patients
adipose tissue distribution [1 day after admission]
The visceral fat area(cm^2) in HFpEF patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Chongqing Medical University	Chongqing		China	400000

Sponsors and Collaborators

Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dongying Zhang, Clinical Professor, Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT05095688

Other Study ID Numbers:

2020-09-19

First Posted:

Oct 27, 2021

Last Update Posted:

Oct 27, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Lipid Metabolism Disorders

Study Results

No Results Posted as of Oct 27, 2021