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

NCT04535726 | Completed

• 1 other identifier: 2020-08
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

obesity; the level of blood pressure; arterial stiffness

Outcome Measures

Primary Outcomes (2)

• Arterial stiffness

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

  On admission

• The level of blood pressure

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

  On admission

Secondary Outcomes (2)

• The change from baseline in quality of life

  6 months

• The re-hospitalization rate of heart failure

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients with preserved ejection fraction (HFpEF)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Related Publications (1)

• Sun M, Gao L, Bai H, Hu W, Zhang X, Xiao J, Deng X, Tao H, Ge P, Qin Y, Zhang D. Association Between Visceral Fat, Blood Pressure and Arterial Stiffness in Patients with HFpEF: A Mediation Analysis. Diabetes Metab Syndr Obes. 2023 Mar 8;16:653-662. doi: 10.2147/DMSO.S399928. eCollection 2023.

  PMID: 36923684 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dongying Zhang, doctor

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Study Start: September 1, 2020
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)