CRAS-HF study

JRCT ID: jRCT1041210164

Registered date:17/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with renal anemia
• Date of first enrollment: 17/03/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

In the vadodustat group, the starting dose is 300 mg of vadodustat orally once daily for 6 months.
In the control group, heart failure treatment will be continued.

Outcome(s)

• Primary Outcome: Change in NT-proBNP before and after 24 weeks treatment

Secondary Outcome

1, Change in NT-proBNP before and after 4 and 12 weeks
treatment
2, 6-minute walking distance
3, NYHA functional classification
4, Clinical symptoms
5, biomarker values

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1, Patients with symptoms of heart failure or a history of heart failure admission with renal anemia.
2, Hb 11g/dL or less within one month.
3, Prescribed standard heart failure drugs.
4, NT pro BNP of 400 pg/mL or more in sinus rhythm or 900/pg mL or more in patients with atrial fibrillation within one month.
5, Chronic renal failure

Exclude criteria

1, Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
2, Predisposition to thrombosis and/or high risk of thrombosis
3, History of thrombotic cerebral infarction or pulmonary embolism
4, Pulmonary hypertension
5, Bleeding complications within 12 weeks
6, Treated cancer within 5 years or malignant tumors that require treatment
7, Hepatic disorder (AST > 100IU/L or ALT > 100IU/L)
8, Myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack within 12 weeks prior to obtaining consent.
9, Patients who have undergone or are scheduled to undergo PCI, CABG, valvuloplasty, or valve replacement within 12 weeks prior to obtaining consent.
10, Performed pacemaker implantation surgery within 12 weeks prior to obtaining consent, or are scheduled to undergo such surgery at the time of obtaining consent.
11, Patients on maintenance hemodialysis or those who are likely to be on hemodialysis within one year.
12, Lactating or pregnant.
13, Proliferative diabetic retinopathy, macular edema, exudative age-related macular degeneration, retinal vein occlusion.
14, Patients with a history of hypersensitivity to the HIF-Phi drug
15, Patients using ESA and HIF-PH inhibitor within 12 weeks.
16, Inappropriated cases

Related Information

• Primary Sponsor: Murohara Toyoaki