The Relationship Between Heart Function and Metabolism in HFpEF Patients

August 23, 2022 updated by: Dongying Zhang, Chongqing Medical University

The Relationship Between Heart Function and Metabolism in Heart Failure With Preserved Ejection Fraction Patients

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

However, heart failure with preserved ejection fraction is difficult to diagnose and treat due to its unknown pathogenesis and poor prognosis. Ventricular diastolic dysfunction and retention of left ventricular ejection fraction are important pathological features of Heart failure with preserved ejection fraction. Currently, it is widely believed to be a clinical syndrome associated with old age, women, obesity, diabetes, hypertension, atrial fibrillation, coronary heart disease, atherosclerosis, etc. However, the specific mechanism of heart failure with preserved ejection fraction caused by the above-mentioned complications is unknown. In conclusion, the investigators intend to explore the pathogenesis of heart failure with preserved ejection fraction by observing the changes of heart and body metabolism in patients with heart failure with preserved ejection fraction, and provide a basis for the diagnosis and treatment.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients with preserved ejection fraction (HFpEF)

Description

Inclusion Criteria:

  • Adult aged ≥ 18 years old
  • Patients diagnosed with HFpEF;

Diagnostic criteria including:

  1. LVEF 50% or higher;
  2. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
  3. Presence of symptoms and/or signs of heart failure;
  4. At least one additional criteria: relevant structure heart disease or diastolic dysfunction

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HFpEF
Heart failure with preserved ejection fraction
HFrEF
Heart failure with reduced ejection fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: On admission
The muscle mass of HFpEF patients, such as thigh muscle mass
On admission
Blood uric acid
Time Frame: On admission
The blood uric acid of HFpEF patients
On admission
Body fat content
Time Frame: On admission
The body fat content of HFpEF patients, such as fat percentage and visceral fat area.
On admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-08-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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