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OpenTrials
Completed

NCT Number: NCT04535726

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

Primary outcomes

  1. Arterial stiffness

    Time frame: On admission

    The arterial stiffness of HFpEF patients, for example brachial ankle pulse wave velocity, ardioankle vascular index and so on.

  2. The level of blood pressure

    Time frame: On admission

    The level of systolic and diastolic blood pressure of heart failure patients with preserved ejection fraction.

Secondary outcomes

  1. The change from baseline in quality of life

    Time frame: 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.

  2. The re-hospitalization rate of heart failure

    Time frame: 6 months

    The re-hospitalization rate of heart failure

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2020
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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