NCT04594499

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.

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 Sep 2020

Typical duration for all trials

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

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

October 15, 2020

Last Update Submit

October 15, 2020

Conditions

Keywords

epicardial fat tissue, 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

  • Epicardial Fat Tissue

    Epicardial Fat Tissue by cardiac color Doppler ultrasound

    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.
  • 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;
  • Primary pulmonary hypertension;
  • 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, China

RECRUITING

Study Officials

  • Dongying Zhang, doctor

    First Affiliated Hospital of Chongqing Medical University

    STUDY DIRECTOR

Central Study Contacts

Dongying Zhang, doctor

CONTACT

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

October 15, 2020

First Posted

October 20, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 20, 2022

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations