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

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT04535726
• Lead Sponsor: Chongqing Medical University

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

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

Study Timeline

• Study First Submitted: 2020-08-28
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-02
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of blood pressure	On admission	The level of systolic and diastolic blood pressure of heart failure patients with preserved ejection fraction.
Arterial stiffness	On admission	The arterial stiffness of HFpEF patients, for example brachial ankle pulse wave velocity, ardioankle vascular index and so on.

Secondary Outcome Measures

Name	Time	Method
The change from baseline in quality of life	6 months	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.
The re-hospitalization rate of heart failure	6 months	The re-hospitalization rate of heart failure

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China