Clin Hypertens.
2017 ;23(1):18. 10.1186/s40885-017-0074-0.
Comparison of effects between calcium channel blocker and diuretics in combination with angiotensin II receptor blocker on 24-h central blood pressure and vascular hemodynamic parameters in hypertensive patients: study design for a multicenter, double-blinded, active-controlled, phase 4, randomized trial
- Affiliations
-
- 1Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
- 2Division of Cardiovascular Disease, Department of Internal Medicine, Gachon University Gil Hospital, Medical Center, Incheon, Korea.
- 3Department of Cardiology, Cardiovascular Center, Seoul St. Mary's Hospital, Seoul, Korea.
- 4Division of Cardiology, St. Paul's Hospital, Seoul, Korea.
- 5Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Seoul, Korea.
- 6Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
- 7Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju Hospital, Wonju, Korea.
- 8Department of Cardiology, Korea University Guro Hospital, Seoul, Korea.
- 9Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.
- 10Division of Cardiology, Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
- 11Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
- 12Cardiovascular Center, Division of Cardiology, Seoul National University Bundang Hospital, Seongnam, Korea.
- 13Division of Cardiology, Department of Internal Medicine, Soonchunhyang Seoul Hospital, Seoul, Korea.
- 14Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Seoul, Korea.
- 15Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Busan, Korea.
- 16Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
- 17Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.
- 18Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.
- 19Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
- 20Cardiovascular Center, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, Korea. chongjinkim@naver.com
- KMID: 2404103
- DOI: http://doi.org/10.1186/s40885-017-0074-0
Abstract
- BACKGROUND
Hypertension is a risk factor for coronary heart disease and stroke, and is one of the leading causes of death. Although over a billion people are affected worldwide, only half of them receive adequate treatment. Current guidelines on antihypertensive treatment recommend combination therapy for patients not responding to monotherapy, but as the number of pills increase, patient compliance tends to decrease. As a result, fixed-dose combination drugs with different antihypertensive agents have been developed and widely used in recent years. CCBs have been shown to be better at reducing central blood pressure and arterial stiffness than diuretics. Recent studies have reported that central blood pressure and arterial stiffness are associated with cardiovascular outcomes. This trial aims to compare the efficacy of combination of calcium channel blocker (CCB) or thiazide diuretic with an angiotensin receptor blocker (ARB).
METHODS
This is a multicenter, double-blinded, active-controlled, phase 4, randomized trial, comparing the antihypertensive effects of losartan/amlodipine and losartan/hydrochlorothiazide in patients unresponsive to treatment with losartan. The primary endpoint is changes in mean sitting systolic blood pressure (msSBP) after 4 weeks of treatment. Secondary endpoints are changes in msSBP, mean 24-h ambulatory mobile blood pressure, mean 24-h ambulatory mobile central SBP, mean 24-h ambulatory carotid-femoral pulse wave velocity, ambulatory augmentation index, and microalbuminuria/proteinuria after 20 weeks of treatment. The sample size will be 119 patients for each group in order to confer enough power to test for non-inferiority regarding the primary outcome.
CONCLUSION
The investigators aim to prove that combination of a CCB with ARB shows non-inferiority in lowering blood pressure compared with a combination of thiazide diuretic and ARB. We also hope to distinguish the subset of patients that are more responsive to certain types of combination drugs. The results of this study should aid physicians in selecting appropriate combination regimens to treat hypertension in certain populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT02294539. Registered 12 November 2014.
Keyword
MeSH Terms
-
Angiotensin II*
Angiotensins*
Antihypertensive Agents
Blood Pressure*
Calcium Channels*
Calcium*
Cause of Death
Coronary Disease
Diuretics*
Hemodynamics*
Hope
Humans
Hypertension
Losartan
Patient Compliance
Pulse Wave Analysis
Receptors, Angiotensin*
Research Personnel
Risk Factors
Sample Size
Stroke
Vascular Stiffness
Angiotensin II
Angiotensins
Antihypertensive Agents
Calcium
Calcium Channels
Diuretics
Losartan
Receptors, Angiotensin
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Chlorthalidone, not hydrochlorothiazide, is the right diuretic for comparison
- Amlodipine Vs. hydrochlorothiazide: is there any disparity in its antihypertensive effect or not?
- A Randomized Crossover Study of the Additive Effect of Lercanidipine and Indapamide in Patients with the Mild to Moderate Hypertension
- Combination therapy of hypertension
- Lithium Intoxication Induced by Angiotensin II Receptor Blocker/Thiazide Combination Agent
