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Набор по приглашению NCT07015554

Serum IGF1 on Female HFpEF Patients

— Наблюдательное HFpEF - Heart Failure With Preserved Ejection Fraction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: HFpEF - Heart Failure With Preserved Ejection Fraction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Study on Serum IGF1 in Female Patients With Heart Failure With Preserved Ejection Fraction

Обзор

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.

Первичные конечные точки

  • IGF1 level [Срок оценки: 0, 3, 6, 12months]
Вторичные конечные точки (7)
  • E2 level [Срок оценки: 0, 3, 6, 12 months]
  • LVPWs [Срок оценки: 0, 3, 6, 12 months]
  • LVIDd [Срок оценки: 0, 3, 6, 12 months]
  • LVIDs [Срок оценки: 0, 3, 6, 12 months]
  • IVSTd [Срок оценки: 0, 3, 6, 12 months]
  • IVSTs [Срок оценки: 0, 3, 6, 12 months]
  • E/e' [Срок оценки: 0, 3, 6, 12 months]

Критерии участия

Критерии включения

  • age over 18;
  • female participants only;

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • The University of Hong Kong-Shenzhen Hospital — Шэньчжэнь

Идентификаторы

NCT: NCT07015554 · 8230-1 · 82300446 · RCBS20231211090745071

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗