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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04535726

Enrollment

200

Registered

2020-09-02

Start date

2020-09-01

Completion date

2022-07-27

Last updated

2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

obesity, the level of blood pressure, arterial stiffness

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results