NCT05059769

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. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. There is no report on whether AASI is associated with left ventricular diastolic dysfunction in patients with HFpEF.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2020

Completed
12 months until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

October 10, 2020

Last Update Submit

September 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Left ventricular diastolic function

    the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e')

    1 day On admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients with preserved ejection fraction (HFpEF)

You may qualify if:

  • Adult aged \>=18years old; Diagnosed with HFpEF.

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 Severe valvular disease of the left heart; Chronically bedridden or incapacitated; Age \<18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated Hospital of Chongqing Medical University

Chongqing, 400042, China

RECRUITING

Central Study Contacts

Zhang Dongying

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 10, 2020

First Posted

September 28, 2021

Study Start

October 10, 2020

Primary Completion

December 31, 2021

Study Completion

April 30, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations