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Olmesartan clinical trial in Okinawan patients under OKIDS (OCTOPUS) study: design and methods
Kunitoshi Iseki1, Kiyoyuki Tokuyama2, Yoshiki Shiohira3
1Dialysis Unit, University Hospital of The Ryukyus, 207 Uehara, Nishihara, Okinawa, 903-0215, Japan. chihokun@med.u-ryukyu.ac.jp.
Insights
This study investigates blood pressure targets and renin-angiotensin system inhibitors for hypertensive hemodialysis patients. Findings will guide treatment for this high-risk cardiovascular disease population.
Area of Science:
- Nephrology
- Cardiology
- Hypertension Management
Background:
- Chronic hemodialysis (HD) patients have high cardiovascular disease (CVD) mortality.
- Hypertension treatment guidelines are lacking for the HD population.
- Survival rates are higher in hypertensive HD patients compared to normotensive or hypotensive patients.
Purpose of the Study:
- To establish target pre-dialysis blood pressure levels for hypertensive HD patients.
- To compare the efficacy of renin-angiotensin system (RAS) inhibitors versus non-RAS inhibitors in this population.
- To evaluate the role of home blood pressure monitoring in managing hypertension in HD patients.
Main Methods:
- Prospective randomized controlled trial (Okinawa Dialysis Study, OKIDS).
- Comparison of Olmesartan (RAS inhibitor) with non-RAS inhibitors in 462 ambulatory HD patients (age 20-79).
- Inclusion criteria: resistant hypertension (pre-HD BP ≥ 140/90 mmHg) for at least 1 month.
Main Results:
- The study aims to provide evidence on optimal blood pressure targets.
- It will determine the impact of RAS inhibitors on mortality and CVD events over 3 years.
- The effectiveness of home blood pressure monitoring will be assessed.
Conclusions:
- This research will offer crucial insights into hypertension management for hemodialysis patients.
- Findings are expected to inform clinical practice regarding blood pressure targets and antihypertensive drug selection.
- The study will highlight the potential benefits of RAS inhibitors and home blood pressure monitoring.
Background:
Guidelines for treatment of hypertension are not available for chronic hemodialysis (HD) population, despite the high mortality rate due to cardiovascular disease (CVD). Survival is much better among hypertensive patients than normal to hypotensive patients. Target levels of blood pressure and the class of antihypertensive drugs have not been examined in prospective studies.
Methods:
We designed a prospective randomized controlled study among hypertensive HD patients in Okinawa (Okinawa Dialysis Study, OKIDS). The outcomes will be compared between two treatment regimens, such as (1) renin-angiotensin system (RAS) inhibitor Olmesartan and others, and (2) antihypertensive drugs without RAS inhibitors, in a parallel fashion. The title of the study is Olmesartan Clinical Trial in Okinawan Patients under OKIDS (OCTOPUS). Outcomes are any cause of death and CVD in 3 years in a total of 462 patients. Subjects are age 20-79 years and ambulatory on thrice weekly HD treatment. Eligible patients have resistant hypertension: pre-HD session blood pressure 140/90 mmHg and over for more than 1 month regardless with the use of antihypertensive drugs. Patients treated with RAS drugs are eligible if they continue to be hypertensive for more than 1 month after switching to non-RAS antihypertensive drugs.
Conclusion:
This study provides evidence for the target levels of blood pressure at a pre-HD session and the impact of RAS inhibitors. We also evaluate the usefulness of home blood pressure monitoring in HD patients.
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