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
NCT number | NCT04535726 |
Other study ID # | 2020-08 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | July 27, 2022 |
Verified date | February 2023 |
Source | Chongqing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Chongqing Medical University | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Chongqing Medical University |
China,
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 |
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