NCT07725484Toborzás még nem indult3. fázis
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Lipoic Acid in Chronic Ischemic Heart Failure: Assessment of Reduction in Major Adverse Cardiovascular Events
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 28.
Rövid összefoglaló (regiszter, angolul)
Chronic heart failure is a clinical condition caused by structural heart disease and is characterized by reduced pumping function, fluid retention, and abnormal activation of neurohormonal systems. It represents the advanced stage of many cardiovascular diseases and remains a major global health challenge. Despite progress in medical and interventional therapies, patients with chronic heart failure continue to experience high rates of death, hospitalization, and long-term disability. Ischemic heart failure, which develops as a result of coronary artery disease and prior myocardial infarction, is the most common form of chronic heart failure. Current treatment strategies, including guideline-directed medical therapy and revascularization procedures, can improve symptoms and outcomes but do not fully address the residual risk of adverse cardiovascular events. Therefore, additional therapeutic approaches are needed to further improve long-term prognosis in this population. Abnormal myocardial energy metabolism is a key pathological feature of heart failure. Mitochondria play a central role in energy production, and impaired mitochondrial function contributes to disease progression. Previous studies by our group have identified mitochondrial aldehyde dehydrogenase 2 (ALDH2) as an important regulator of myocardial metabolic homeostasis and cardiac protection under ischemic and stress conditions. Alpha-lipoic acid is a vitamin B-related compound with antioxidant properties and has been widely used in clinical practice for other indications. Increasing evidence suggests that alpha-lipoic acid may also exert protective effects in cardiovascular diseases, potentially through modulation of mitochondrial function. Experimental studies have shown that alpha-lipoic acid can restore ALDH2 activity and improve cardiac function in models of heart failure. Based on these findings, we conducted an exploratory randomized controlled trial between 2019 and 2023 to evaluate the safety and potential efficacy of alpha-lipoic acid in patients with ischemic heart failure. In this multicenter study, patients receiving alpha-lipoic acid showed favorable trends toward reduced risk of death and heart failure-related hospitalization, as well as significant improvements in left ventricular ejection fraction and exercise capacity, without an increase in adverse events. Taken together, prior mechanistic research and early clinical evidence support the hypothesis that alpha-lipoic acid may provide additional benefit when used as adjunctive therapy in patients with chronic ischemic heart failure. The present study is designed to further evaluate whether long-term supplementation with alpha-lipoic acid can reduce major adverse cardiovascular events and improve clinical outcomes in this population.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1188 (tervezett)
- Első benyújtás
- 2026. júl. 21.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2030. nov. 1.
- Fő szponzor
- Shanghai Zhongshan Hospital
- Betegségek
- Koszorúér-betegség, Szívelégtelenség
- NCT-szám
- NCT07725484
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 1188
- 2026. nov. 1. és az elsődleges befejezés (2030. nov. 1.) között
- 23 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Previous cardiac resynchronization therapy (CRT);
- Participation in another investigational drug trial within 4 weeks prior to enrollment or ongoing receipt of any investigational treatment other than the study medication;
Más betegség
- Uncontrolled malignant arrhythmias or progressively worsening unstable angina;
- Malignancies, lymphoma, leukemia, or other serious conditions associated with a life expectancy of less than 1 year;
- Known hypersensitivity or allergy to vitamin B preparations;
- Heart failure caused by restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or primary valvular heart disease;
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Laborértékek
- Severe hepatic dysfunction, defined as serum transaminase levels exceeding 3 times the upper limit of normal (ULN), or severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²;
Egyéb
- Participants meeting any of the following criteria will be excluded:
- Pregnant or breastfeeding women;
- Hemodynamic instability;
Kiket keres a vizsgálat
- Participants must meet all of the following criteria:
- Aged ≥18 years and <75 years;
- A history of chronic heart failure for more than 3 months or clinically documented symptoms of heart failure persisting for more than 3 months;
- Left ventricular ejection fraction (LVEF) <50% as assessed by echocardiography;
- A history of acute myocardial infarction (AMI) more than 3 months prior to enrollment;
- New York Heart Association (NYHA) functional class II-IV;
- Receipt of guideline-directed medical therapy (GDMT) for at least 2 weeks;
- Willingness to participate in the study, with the ability to understand and provide written informed consent.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (23)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The First Affiliated Hospital of Dalian Medical University | Dalian | Kína | Ismeretlen állapot |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Kína | Ismeretlen állapot |
| Fujian Provincial Hospital | Fuzhou | Kína | Ismeretlen állapot |
| Guangdong Provincial People'S Hospital | Guangdong | Kína | Ismeretlen állapot |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Kína | Ismeretlen állapot |
| The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of USTC(Anhui Provincial Hospital) | Hefei | Kína | Ismeretlen állapot |
| Qilu Hospital of Shandong University | Jinan | Kína | Ismeretlen állapot |
| Affiliated Hospital of Jining Medical University | Jining | Kína | Ismeretlen állapot |
| Luoyang Central Hospital Affiliated to Zhengzhou University | Luoyang | Kína | Ismeretlen állapot |
| Zhongda Hospital Southeast University | Nanjing | Kína | Ismeretlen állapot |
| The Affiliated Hospital of Qingdao University | Qingdao | Kína | Ismeretlen állapot |
| Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University) | Quzhou | Kína | Ismeretlen állapot |
| Shanghai East Hospital, Tongji University School of Medicine | Shanghai | Kína | Ismeretlen állapot |
| Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital | Shanghai | Kína | Ismeretlen állapot |
| Shanghai Putuo District Central Hospital | Shanghai | Kína | Ismeretlen állapot |
| Wusong Hospital, Zhongshan Hospital, Fudan University | Shanghai | Kína | Ismeretlen állapot |
| Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University | Shanghai | Kína | Ismeretlen állapot |
| Zhongshan Hospital,Fudan University | Shanghai | Kína | Ismeretlen állapot |
| Shanxi Cardiovascular Hospital | Taiyuan | Kína | Ismeretlen állapot |
| The Second Hospital of Shanxi Medical University | Taiyuan | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Kína | Ismeretlen állapot |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.