Serum IGF1 on Female HFpEF Patients

NCT07015554 | Enrolling By Invitation

• 3 other identifiers: 8230-182300446RCBS20231211090745071
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Study Title: Application of Serum IGF1 in the Diagnosis of Female Heart Failure with Preserved Ejection Fraction (HFpEF) Study Institution: Hong Kong University-Shenzhen Hospital Principal Investigator: Sidong Cai

1. 1.Study Purpose This study aims to investigate whether serum insulin-like growth factor 1 (IGF1) can be used to improve the diagnosis of heart failure with preserved ejection fraction (HFpEF) in women, providing preliminary insights for early detection of this condition in female patients.
2. 2.Study Procedures Information Collection: Relevant medical information will be collected during your outpatient visit or hospitalization.
3. 3.Risks and Discomforts Confidentiality: All information will be kept strictly confidential.
4. 4.Responsibilities as a Research Subject
5. 5.Privacy Protection Anonymization: Blood samples will be labeled with your study number, not your name.
6. 6.Compensation for Study-Related Injuries In the event of a study-related injury, you are entitled to compensation in accordance with Chinese law.
7. 7.Voluntary Participation and Withdrawal You may refuse to participate or withdraw from the study at any time. Withdrawal will not affect your medical care or rights. Data collected before withdrawal will be excluded from the study results upon your request.
8. 8.Contact Information For questions about the study, your rights, or any discomfort/injury during the study, please contact Principal Investigator: Dr. Sidong Cai via caisd@hku-szh.org.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

Insulin growth factor (IGF1); Heart failure with preserved ejection fraction (HFpEF)

Outcome Measures

Primary Outcomes (1)

• IGF1 level

  IGF1 level in serum of the enrolled participants

  0, 3, 6, 12months

Secondary Outcomes (7)

• E2 level

  0, 3, 6, 12 months

• LVPWs

  0, 3, 6, 12 months

• LVIDd

  0, 3, 6, 12 months

• LVIDs

  0, 3, 6, 12 months

• IVSTd

  0, 3, 6, 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population was divided into two part: (1) Healthy population; (2) HFpEF population. For healthy population, candidates are female sex, age over 18, without any congenital heart defects or heart diseases. For HFpEF population, candidates are female sex, age over 18, with HFpEF diagnosis or all criteria mentioned below: * Clinical manifestations-Typical symptoms of heart failure (such as decreased activity tolerance, sitting breathing) or signs (such as moist rales in the lungs, edema of the lower extremities); * Left ventricular ejection fraction (LVEF) -LVEF ≥50% without significant dilation in the left ventricle; * Evidence of cardiac structural or functional abnormalities-LAVI\>34 mL/m², LVMI \>95 g/m², E/e' ratio \>15, tricuspid regurgitation velocity \>2.8 m/s, etc. * Biomarker: BNP≥35 pg/mL or NT-proBNP≥125 pg/mL (patients with sinus rhythm) ⑤ Without cardiac amyloidosis, hypertrophic cardiomyopathy, valvular heart disease, pericardial disease and lung/kidney disease

You may qualify if:

• age over 18;
• female participants only;

You may not qualify if:

• with congenital heart disease or with other family disease history
• participants receiving hormone therapy

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead

Study Sites (1)

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Fellow

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)