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CRAS-HF study

A Randomized, Controlled Study of HIF-PH Inhibitors in patients with Heart Failure and Renal Anemia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1041210164
Enrollment
40
Registered
2022-03-17
Start date
2022-03-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with renal anemia Renal anemia

Interventions

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.

Sponsors

Murohara Toyoaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Change in NT-proBNP before and after 24 weeks treatment

Secondary

MeasureTime frame
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

Contacts

Public ContactRyota Morimoto

Department of Cardiology, Nagoya University Graduate School of Medicine

ryota.m0726@med.nagoya-u.ac.jp+81-52-744-2168

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026