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Clin Hypertens. 2017 Sep 4;23:18. doi: 10.1186/s40885-017-0074-0. eCollection 2017.

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.

Author information

1
Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
2
Division of Cardiovascular Disease, Department of Internal Medicine, Gachon University Gil Hospital, Medical Center, Incheon, Korea.
3
Department of Cardiology, Cardiovascular Center, Seoul St. Mary's Hospital, Seoul, Korea.
4
Division of Cardiology, St. Paul's Hospital, Seoul, Korea.
5
Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Seoul, Korea.
6
Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
7
Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju Hospital, Wonju, Korea.
8
Department of Cardiology, Korea University Guro Hospital, Seoul, Korea.
9
Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Korea.
10
Division of Cardiology, Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
11
Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
12
Cardiovascular Center, Division of Cardiology, Seoul National University Bundang Hospital, Seongnam, Korea.
13
Division of Cardiology, Department of Internal Medicine, Soonchunhyang Seoul Hospital, Seoul, Korea.
14
Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Seoul, Korea.
15
Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Busan, Korea.
16
Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
17
Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.
18
Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.
19
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
20
Cardiovascular Center, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, Korea.

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.

KEYWORDS:

Angiotensin II receptor blocker; Arterial stiffness; Calcium channel blocker; Central blood pressure; Fixed dose combination; Hypertension

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