SAVANT study

JRCT ID: jRCT1041240078

Registered date:29/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertension caused by Angiogenesis Inhibitor
• Date of first enrollment: 29/08/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patient with hypertension due to angiogenesis inhibitor is treated with combination therapy of sacubitril/valsartan200mg and amlodipine5mg. Changes of blood pressure are monitored for 3 weeks (+- 1 week) after the start of treatment.

Outcome(s)

• Primary Outcome: Rate of blood pressure control

Secondary Outcome

Adverse events
Change of blood-pressure value

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Pathologically diagnosed with cancer
(2) Diagnosed with drug-induced hypertension caused by angiogenesis inhibitors
(3) One calcium antagonist or ARB/ACE inhibitor is used
(4) Angiogenesis inhibitor is continued.
(5) Creatinine is less than 1.5 mg/dL
(6) 18 years or older
(7) Written informed consent was obtained

Exclude criteria

(1)Severe hypertention (CTCAEv5, Grade4)
(2)Essential hypertension (Blood pressure 140/90mmHg or more before starting treatment with angiogenesis inhibitors)
(3)History of secondary hypertension

Related Information

• Primary Sponsor: Oyakawa Takuya