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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.

Abstract 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).
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Mayor MeshTerms
Keywords

Angiotensin II receptor blocker

Arterial stiffness

Calcium channel blocker

Central blood pressure

Fixed dose combination

Hypertension

Journal Title clinical hypertension
Publication Year Start




PMID- 28879040
OWN - NLM
STAT- PubMed-not-MEDLINE
DA  - 20170907
LR  - 20170910
IS  - 2056-5909 (Print)
IS  - 2056-5909 (Linking)
VI  - 23
DP  - 2017
TI  - 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.
PG  - 18
LID - 10.1186/s40885-017-0074-0 [doi]
AB  - 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.
FAU - Oh, Gyu Chul
AU  - Oh GC
AD  - Division of Cardiology, Department of Internal Medicine, Seoul National
      University Hospital, Seoul, Korea.
FAU - Lee, Hae-Young
AU  - Lee HY
AD  - Division of Cardiology, Department of Internal Medicine, Seoul National
      University Hospital, Seoul, Korea.
FAU - Chung, Wook Jin
AU  - Chung WJ
AD  - Division of Cardiovascular Disease, Department of Internal Medicine, Gachon
      University Gil Hospital, Medical Center, Incheon, Korea.
FAU - Youn, Ho-Joong
AU  - Youn HJ
AD  - Department of Cardiology, Cardiovascular Center, Seoul St. Mary's Hospital,
      Seoul, Korea.
FAU - Cho, Eun-Joo
AU  - Cho EJ
AD  - Division of Cardiology, St. Paul's Hospital, Seoul, Korea.
FAU - Sung, Ki-Chul
AU  - Sung KC
AD  - Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Seoul, 
      Korea.
FAU - Chae, Shung Chull
AU  - Chae SC
AD  - Division of Cardiology, Department of Internal Medicine, Kyungpook National
      University Hospital, Daegu, Korea.
FAU - Yoo, Byung-Su
AU  - Yoo BS
AD  - Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju 
      Hospital, Wonju, Korea.
FAU - Park, Chang Gyu
AU  - Park CG
AD  - Department of Cardiology, Korea University Guro Hospital, Seoul, Korea.
FAU - Hong, Soon Jun
AU  - Hong SJ
AD  - Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 
      Seoul, Korea.
FAU - Kim, Young Kwon
AU  - Kim YK
AD  - Division of Cardiology, Department of Internal Medicine, Dongguk University Ilsan
      Hospital, Goyang, Korea.
FAU - Hong, Taek-Jong
AU  - Hong TJ
AD  - Division of Cardiology, Department of Internal Medicine, Pusan National
      University Hospital, Busan, Korea.
FAU - Choi, Dong-Ju
AU  - Choi DJ
AD  - Cardiovascular Center, Division of Cardiology, Seoul National University Bundang 
      Hospital, Seongnam, Korea.
FAU - Hyun, Min Su
AU  - Hyun MS
AD  - Division of Cardiology, Department of Internal Medicine, Soonchunhyang Seoul
      Hospital, Seoul, Korea.
FAU - Ha, Jong Won
AU  - Ha JW
AD  - Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular
      Hospital, Seoul, Korea.
FAU - Kim, Young Jo
AU  - Kim YJ
AD  - Division of Cardiology, Department of Internal Medicine, Yeungnam University
      Hospital, Busan, Korea.
FAU - Ahn, Youngkeun
AU  - Ahn Y
AD  - Division of Cardiology, Department of Internal Medicine, Chonnam National
      University Hospital, Gwangju, Korea.
FAU - Cho, Myeong Chan
AU  - Cho MC
AD  - Division of Cardiology, Department of Internal Medicine, Chungbuk National
      University Hospital, Cheongju, Korea.
FAU - Kim, Soon-Gil
AU  - Kim SG
AD  - Division of Cardiology, Department of Internal Medicine, Hanyang University Guri 
      Hospital, Guri, Korea.
FAU - Shin, Jinho
AU  - Shin J
AD  - Division of Cardiology, Department of Internal Medicine, Hanyang University Guri 
      Hospital, Guri, Korea.
FAU - Park, Sungha
AU  - Park S
AD  - Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular
      Hospital, Seoul, Korea.
FAU - Sohn, Il-Suk
AU  - Sohn IS
AD  - Division of Cardiology, Department of Internal Medicine, Kyung Hee University
      Hospital at Gangdong, Seoul, Korea.
FAU - Kim, Chong-Jin
AU  - Kim CJ
AD  - Division of Cardiology, Department of Internal Medicine, Kyung Hee University
      Hospital at Gangdong, Seoul, Korea.
AD  - Cardiovascular Center, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro,
      Gangdong-gu, Seoul, Korea.
LA  - eng
PT  - Journal Article
DEP - 20170904
PL  - England
TA  - Clin Hypertens
JT  - Clinical hypertension
JID - 101669508
PMC - PMC5584029
OTO - NOTNLM
OT  - Angiotensin II receptor blocker
OT  - Arterial stiffness
OT  - Calcium channel blocker
OT  - Central blood pressure
OT  - Fixed dose combination
OT  - Hypertension
EDAT- 2017/09/08 06:00
MHDA- 2017/09/08 06:01
CRDT- 2017/09/08 06:00
PHST- 2017/04/23 [received]
PHST- 2017/08/18 [accepted]
AID - 10.1186/s40885-017-0074-0 [doi]
AID - 74 [pii]
PST - epublish
SO  - Clin Hypertens. 2017 Sep 4;23:18. doi: 10.1186/s40885-017-0074-0. eCollection
      2017.