ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613001021763

Ethics application status

Approved

Date submitted

11/09/2013

Date registered

13/09/2013

Date last updated

6/08/2019

Date data sharing statement initially provided

6/08/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Treatment of disordered blood pressure in spinal cord injury

Scientific title

A double-blind, placebo controlled, crossover study of a nocturnal dose of captopril to determine its effect on diurnal blood pressure and orthostatic symptoms in people with spinal cord injury

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1147-8242

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Orthostatic intolerance

Hypotension

Diurnal blood pressure

Nocturnal polyuria

Spinal cord injury

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Neurological

Other neurological disorders

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Captopril, orally, nightly, starting at 25mg and uptitrating by 25mg a week to a maximum of 100mg over a 4 week titration phase, followed by maintenance phase for 4 weeks at the highest dose reached. Unused capsules to be returned at the end of each treatment arm. Washout period of 2 weeks between treatment arms.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo - microcellulose capsule
Placebo and captopril capsules are packaged to look identical

Control group

Placebo

Outcomes

Primary outcome [1]

Mean daytime blood pressure - measured by ambulatory blood pressure monitoring

Timepoint [1]

Before and after each treatment arm

Secondary outcome [1]

Degree of nocturnal dipping - ratio of mean night:day systolic blood pressure as measured by ambulatory blood pressure monitoring

Timepoint [1]

Before and after each treatment arm

Secondary outcome [2]

Orthostatic hypotension questionnaire symptom scale

Timepoint [2]

Before and after each treatment arm

Secondary outcome [3]

Nocturnal urine production - volume of urine produced overnight expressed as a percentage of the entire day's urine volume; calculated from a diary kept over 3 consecutive days

Timepoint [3]

Before and after each treatment arm

Eligibility

Key inclusion criteria

Traumatic spinal cord injury
Age 18 years or greater
Able to provide informed consent
Symptoms of orthostatic intolerance

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Known hypersensitivity to captopril or any other ACE inhibitor
Significant renal impairment
Persistent hyperkalaemia
Recent changes or titration of antihypertensive agents or intention to do so within duration of study
Presence of any other significant medical conditions likely to influence ability to co-operate or prevent adherence to protocol, or where treatment with captopril would put the participant at increased risk of adverse events or drug interactions
Pregnancy or breastfeeding

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Enrolled participants are allocated sequential randomisation numbers, where the randomisation schedule is held by the Department of Pharmacy, hence the investigators, assessors and participants remain blinded to treatment allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Crossover

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

The sample demographics, blood pressure and symptom scores will be described using descriptive and summary statistics. Comparisons of symptoms, blood pressure, autonomic function and urine measures between the treatment and placebo groups will be made using parametric (e.g. paired t-tests) or repeated measures analysis of variance as appropriate. Blood pressure will also be plotted across assessment points. Blood pressure, autonomic functioning and urine measures will be correlated with symptoms.

Assuming a total of 25 patients enter this two-treatment crossover study, the probability is 80 percent that the study will detect a treatment difference at a two-sided 0.05 significance level, if the true difference between treatments is 10 mmHg. This is based on the assumption that the within-patient standard deviation of the systolic blood pressure is 12 mmHg.

Recruitment

Recruitment status

Stopped early

Data analysis

No data analysis planned

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

9/08/2013

Actual

9/08/2013

Date of last participant enrolment

Anticipated

Actual

5/12/2013

Date of last data collection

Anticipated

Actual

22/03/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Transport Accident Commission

Address [1]

Level 6, 60 Brougham Street
Geelong, VIC 3220
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Hospital

Address

Austin Hospital
145 Studley Road
Heidelberg Vic 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Office for Research,
Austin LifeSciences
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/02/2013

Approval date [1]

02/05/2013

Ethics approval number [1]

H2013 / 04981

Summary

Brief summary

Spinal cord injury (SCI) results in permanent paralysis and significant disability. In addition, some spinal cord injured people experience postural hypotension, a large drop in blood pressure when assuming the upright position, associated with dizziness and fainting. For someone with SCI who is wheelchair dependent, fainting can have significant consequences such as further injury from falling out of the chair, reduced independence and limited vocational outcomes, thus poorer overall physical and psychological well-being.
In SCI, interruption of nervous communications, along with the loss of muscle pump in the legs, results in the impaired ability to maintain blood pressure on getting upright. Such persons have an abnormal pattern of blood pressure, whereby the blood pressure does not drop overnight, unlike the usual pattern. In some cases, there is even a higher blood pressure during the night than during the day – opposite to the normal pattern.
Higher night time blood pressure leads to increased night time urine production, leaving the body with relatively less circulating blood volume in the morning, at the time that one is about to get out of bed, further contributing to postural hypotension.
This study aims to examine the effects of treatment with captopril, a blood pressure lowering medication, at night, in a person with SCI who experiences symptoms of postural hypotension; we hypothesise that lowering night time blood pressure will reduce night time urine production, therefore increase blood pressure during the day, and reduce symptoms of postural hypotension, allowing the ability to stay upright during the day to carry out activities.
In this placebo controlled crossover study, participants will receive either the drug treatment or a placebo (dummy pill) for 8 weeks, and then switch to the other pill to determine if there is a difference in effects between the two. Each treatment period will be separated by two weeks where the participant is not on
either pill. Before and after each treatment, assessments include: measurements of blood pressure profile over 24 hours using an automatic portable monitor, recording urine volumes for 4 days, analysis of urine and blood samples.
Current treatment for such blood pressure disturbances and symptoms of low blood pressure are inadequate, and this study will help to determine whether this novel treatment is effective.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Christopher O'Callaghan

Address

Department of Clinical Pharmacology
Harold Stokes Building Level 5
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg Vic 3084

Country

Australia

Phone

61 3 9496 5029

Fax

61 3 9496 3221

christopher.o'callaghan@austin.org.au

Contact person for public queries

Name

Melinda Millard

Address

Victorian Spinal Cord Service
Harold Stokes Building Level 8
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg Vic 3084

Country

Australia

Phone

61 3 9496 5906

Fax

melinda.millard@austin.org.au

Contact person for scientific queries

Name

Min Yin Goh

Address

Department of Clinical Pharmacology
Harold Stokes Building Level 5
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg Vic 3084

Country

Australia

Phone

61 3 9496 5029

Fax

61 3 9496 3221

min.goh@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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