Condition category
Circulatory System
Date applied
30/12/2011
Date assigned
24/01/2012
Last edited
16/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zejun Tian

ORCID ID

Contact details

215 Hepingxi Road
Department of Cardiology
Second Hospital of Hebei Medical University
Hebei Province
Shijiazhuang
050000
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10276101D

Study information

Scientific title

Plasma renin test guided drug treatment algorithm for correcting different subtypes of hypertension in treated but uncontrolled patients: a randomized trial

Acronym

Study hypothesis

Laragh et al have recently demonstrated in a randomized clinical trial that the renin test guided therapeutic (RTGT) algorithm, an approach they developed based on physiological analyses of pathogenesis of hypertension for selecting antihypertensive drugs to lower blood pressure (BP), worked better than clinical hypertension specialists care (CHSC) in treated but uncontrolled hypertensive patients. It remains unclear, however, whether RTGT works equally well in lowing BP in the patients with different hypertension subtypes, namely, isolated diastolic hypertension (IDH), systolic diastolic hypertension (SDH) and isolated systolic hypertension (ISH), which are commonly believed to be different in physiological abnormalities contributing to elevated BP, such that SDH arises from concomitant increase in both central arterial stiffness and peripheral vascular resistance, ISH reflects increased central arterial stiffness alone, and IDH is a consequence of an increase only in peripheral vascular resistance. The present study is, therefore, to examine a hypothesis that there might be different responses to RTGT between the patients with different hypertension subtypes.

Ethics approval

Research Ethics Committee, Second Hospital of Hebei Medical University, November 2009, ref: 09109

Study design

Randomized non-blinded open labelled controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension, treated but uncontrolled

Intervention

RTGT: The antihypertensive drugs were chosen based on the renin test guided therapeutic (RTGT) algorithm

Senior General Cardiologists’ Care (SGCC): The antihypertensive drugs were chosen based on the physicians personal judgment unaware of patients plasma renin activity (PRA) values.

Contact details of the Joint Principal Investigator:
Prof Yuming Hao
Department of Cardiology
Second Hospital of Hebei Medical University
No. 215, Hepingxi Road
Shijiazhuang, Hebei
China, 050000
haoyuming@medmail.com.cn

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Differences in change in BPs between RTGT and SGCC groups with the three hypertension subtypes, respectively, and between the three hypertension subtypes within RTGT group.

Secondary outcome measures

Differences in change in the antihypertensive drug number between RTGT and SGCC groups with the three hypertension subtypes, respectively, and between the three hypertension subtypes within RTGT group.

Overall trial start date

02/11/2009

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Established hypertensive patients
2. 18 years or older
3. Male or female of any race or ethnicity
4. Have never had anti-hypertensive medication
5. Have had anti-hypertensive medication but not for at least two weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Any comorbidities requiring the medications that interferes with blood pressure (BP) levels (e.g. non-steroidal anti-inflammatory drugs with the exception of aspirin)
2. Any contraindications to any types of antihypertensive drug applied in this study (e.g. asthma)
3. Any situations leading to poor adherence to the study protocol (e.g. mental illness or instability in BP levels e.g. cardiovascular neurosis)
4. Home BP 135/85 mmHg
5. History of white-coat hypertension
6. Serum creatinine >2.5 mg/dl

Recruitment start date

02/11/2009

Recruitment end date

30/06/2012

Locations

Countries of recruitment

China

Trial participating centre

215 Hepingxi Road
Shijiazhuang
050000
China

Sponsor information

Organisation

Second Hospital of Hebei Medical University (China)

Sponsor details

215 Heping Road
Hebei Province
Shijiazhuang
050000
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Hebei Science and Technology Agency (China) (ref: 10276101D)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes