Logo

American Heart Association

  27
  0


Final ID:

DDCI-01 in Pulmonary Arterial Hypertension: A Multicenter Phase II Randomized Active-Controlled Trial

Abstract Body (Do not enter title and authors here): Background
DDCI-01, a novel, highly selective long-acting phosphodiesterase type 5 inhibitor, shows promise as a treatment for pulmonary arterial hypertension (PAH).

Methods
Seventy-two PAH patients were equally randomized to group receiving DDCI-01 (2.5, 10, or 20 mg qd) or tadalafil (0—4 weeks 20mg qd, 5—12weeks 40mg qd) for 12 weeks. The primary efficacy endpoints were changes from baseline to week 12 in hemodynamics by right heart catheterization. The key secondary efficacy endpoints included changes from baseline to week 12 in cardiac function by cardiac magnetic resonance. Treatment-emergent adverse events were evaluated.

Results
Baseline characteristics were well-balanced across groups. The mean age of participants was 41.9 years, and 78.9% were female. At week 12, DDCI-01 produced reduction in pulmonary vascular resistance (-4.3 Wood U in 10 mg group; -3.0 Wood U in 20 mg group), increase in mixed venous oxygen saturation (5.1% in 10 mg group), and cardiac index (0.8 L/min/m2 in 10 mg group). The increase in cardiac index was significantly greater in DDCI-01 10 mg group versus the tadalafil group (least squares mean difference [LSMD], 0.6 L/min/m2; 95% CI, 0.2 to 1.0; P = .007). Also, DDCI-01 10 mg significantly improved right ventricular ejection fraction (8.5%), with a greater increase versus tadalafil (LSMD, 6.0%; 95% CI, 0.4 to 11.6; P = .038). No treatment-emergent severe adverse events occurred in DDCI-01 2.5 mg group and 10 mg group, whereas 3 (16.7%) in both DDCI-01 20 mg group and tadalafil group.

Conclusion
DDCI-01 10 mg tented to improve hemodynamics and cardiac function in PAH and was well tolerated, supporting further development in phase 3 trials.
  • Liu, Chao  ( Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University , Guangzhou , China )
  • Huang, Wei  ( Chongqing Medical University , Chongqing , China )
  • Li, Xian-mei  ( Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University , Guangzhou , China )
  • Xu, Xi-qi  ( Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing , China )
  • Jing, Zhi-cheng  ( Guangdong Provincial People's Hospi , Guangzhou , China )
  • Wang, Li-ting  ( Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University , Guangzhou , China )
  • Dai, Hai-long  ( Yan'an Hospital of Kunming city , Kunming , China )
  • Li, Jiang  ( The Second Xiangya Hospital of Central South University , Changsha , China )
  • Cao, Yunshan  ( Gansu Provincial Hospital , Lanzhou , China )
  • Wu, Bing-xiang  ( The Second Affiliated Hospital of Harbin Medical University , Harbin , China )
  • Yao, Hua  ( Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University , Guangzhou , China )
  • Yu, Zai-xin  ( Xiangya Hospital Central South University , Changsha , China )
  • Zhang, Rui-feng  ( Zhongda Hospital of Southeast University , Nanjing , China )
  • Author Disclosures:
    Chao Liu: DO NOT have relevant financial relationships | Wei Huang: DO NOT have relevant financial relationships | Xian-Mei Li: No Answer | Xi-Qi Xu: No Answer | Zhi-Cheng Jing: DO NOT have relevant financial relationships | Li-Ting Wang: No Answer | Hai-Long Dai: DO NOT have relevant financial relationships | Jiang Li: No Answer | YUNSHAN CAO: No Answer | Bing-Xiang Wu: DO NOT have relevant financial relationships | Hua Yao: No Answer | Zai-Xin Yu: No Answer | Rui-Feng Zhang: No Answer
Meeting Info:

Scientific Sessions 2025

2025

New Orleans, Louisiana

Session Info:

Arteries and Veins in Trouble: VTE and PAD

Saturday, 11/08/2025 , 09:45AM - 11:00AM

Featured Science

More abstracts on this topic:
A major effect of aprocitentan on albuminuria in patients with resistant hypertension

Schlaich Markus, Bakris George, Flack John, Gimona Alberto, Narkiewicz Krzysztof, Sassi-sayadi Mouna, Wang Jiguang, Weber Michael

A Curious Complete Heart Block with Carfilzomib

Shah Mohammed, Rahman Naveed, Al-mohamad Talal, Batra Sejal, Vyas Apurva

More abstracts from these authors:
Decreased Nocturnal Very Low Frequency of Heart Rate Variability Linked to Adverse Cardiovascular Events in Patients with Hypertension

Wang Ling, Lu Xiaozhao, Liu Jin, Ruan Huangtao, Li Yijia, Ma Wei-guo, Jing Zhi-cheng

Nocturnal Very Low Frequency of Heart Rate Variability Predicts Adverse Cardiovascular Events in Obese Individuals

Wang Ling, Ruan Huangtao, Liu Jin, Lu Xiaozhao, Li Yijia, Ma Wei-guo, Jing Zhi-cheng

You have to be authorized to contact abstract author. Please, Login
Not Available