NCT05053256

Brief Summary

HFpEF has gradually become the most common form of heart failure. Studies have found that metabolic abnormalities and chronic inflammation ultimately lead to HFpEF by promoting heart remodeling. However, there are few relevant studies and the mechanism is still unclear.

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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

August 30, 2021

Last Update Submit

August 23, 2022

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (3)

  • Muscle mass

    The muscle mass of HFpEF patients, such as thigh muscle mass

    On admission

  • Blood uric acid

    The blood uric acid of HFpEF patients

    On admission

  • Body fat content

    The body fat content of HFpEF patients, such as fat percentage and visceral fat area.

    On admission

Study Arms (2)

HFpEF

Heart failure with preserved ejection fraction

HFrEF

Heart failure with reduced ejection fraction

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 ≥ 18 years old
  • Patients diagnosed with HFpEF;
  • Diagnostic criteria including:
  • LVEF 50% or higher;
  • BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
  • Presence of symptoms and/or signs of heart failure;
  • At least one additional criteria: relevant structure heart disease or diastolic dysfunction

You may not qualify if:

  • Severe liver failure;
  • Other causes of shortness of breath, such as severe pulmonary disease or severe ● chronic obstructive pulmonary disease;
  • Primary pulmonary hypertension.
  • Severe left valvular heart disease.
  • Long-term bedridden or unable to move autonomously
  • Age \< 18

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

+8613608398395zdy.chris@qq.com

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 30, 2021

First Posted

September 22, 2021

Study Start

October 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)