Serum IGF1 on Female HFpEF Patients

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. 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. Study Procedures Information Collection: Relevant medical information will be collected during your outpatient visit or hospitalization. Subject Identification: If you agree to participate, you will be assigned a unique study number to establish a medical record file. Blood Sampling: Blood samples will be collected concurrently with routine clinical blood draws (no additional needle insertions). Volume: 10-20 mL of venous blood each time, collected on the enrollment day, 3 months, 6 months, and 12 months after enrollment. Use of Samples: Samples will be used exclusively for this study. Follow-up Examinations: Standard HF follow-up tests (e.g., echocardiograms) will be conducted as clinically necessary. These are part of routine HF management and will not impose extra burden on you. 3. Risks and Discomforts Confidentiality: All information will be kept strictly confidential. Minimal Risks: Temporary pain, bruising, or tenderness at the blood draw site. Rarely, mild dizziness or (extremely rarely) needle site infection. 4. Responsibilities as a Research Subject You are required to: Provide truthful information about your medical history and current health status. Report any discomfort experienced during the study to the research doctor. Avoid taking restricted medications or foods as instructed. Disclose if you are currently participating in, or have recently participated in, other research studies. 5. Privacy Protection Anonymization: Blood samples will be labeled with your study number, not your name. Confidentiality: Identifiable information will not be disclosed to anyone outside the research team without your permission. Research staff and the sponsor are obligated to maintain your privacy. Records will be stored in locked cabinets and accessible only to authorized researchers. Regulatory agencies or ethics committees may review your data (anonymized) to ensure study compliance. No personal identifying information will be disclosed in study publications. 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. 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. The researcher may terminate your participation if you fail to follow the protocol, require other treatments, experience study-related injuries, or for other medical reasons. 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.

NCT Number	NCT07015554
Lead Sponsor	The University of Hong Kong-Shenzhen Hospital
Conditions	HFpEF - Heart Failure With Preserved Ejection Fraction
Enrollment	120 participants
Start Date	2025-01-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-11