The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535726
• Other study ID #: 2020-08
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: July 27, 2022

Study information

• Verified date: February 2023
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 blood pressure and arterial stiffness in HFpEF patients with different levels of obesity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult aged >=18years old;

• Diagnosed with HFpEF.

Diagnostic criteria including:

1. left ventricular ejection fraction =50%;

2. with the symptoms and/or signs of heart failure;

3. BNP=35 pg/mL and/or NTproBNP=125 pg/mL;

4. 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;

• Other causes of shortness of breath, such as severe pulmonary disease or severe chronic obstructive pulmonary disease;

• Primary pulmonary hypertension;

• Severe valvular disease of the left heart;

• Chronically bedridden or incapacitated;

• Age <18 years old.

Related Conditions & MeSH terms

• Heart Failure With Preserved Ejection Fraction
• Obesity

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness	The arterial stiffness of HFpEF patients, for example brachial ankle pulse wave velocity, ardioankle vascular index and so on.	On admission
Primary	The level of blood pressure	The level of systolic and diastolic blood pressure of heart failure patients with preserved ejection fraction.	On admission
Secondary	The change from baseline in quality of life	Measured by Minnesota living with heart failure questionnaire. The score ranges from 0 to 105. The higher score means the worse health-related quality of life.	6 months
Secondary	The re-hospitalization rate of heart failure	The re-hospitalization rate of heart failure	6 months