PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study

Study Overview
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Brief Summary
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The purpose of this study is to examine if chronic paracetamol dosing increases blood pressure in patients with known high blood pressure.

Detailed Description
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A prospective randomised, double-blind, crossover trial, comparing the effects of paracetamol 1g (500mg x2) four times daily with matched placebo on ambulatory and clinic BP, each given for 14 days, with a 14-day washout period.

Official Title
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PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study

Conditions
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Blood Pressure

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old, men or post-menopausal women (women with no periods for 12 months or more, or those who have had a surgical menopause) Treated hypertensive patients with an average daytime ambulatory blood pressure measurement (ABPM) <150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACE inhibitor, angiotensin receptor blocker or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM ≥135/85 but <150/95. Exclusion Criteria: History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST>50IU/L) or stage 3-5 chronic kidney disease. History of overdose or suicidal ideation Patients weighing <55kgs. Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of non-steroidal anti-inflammatories , oral anticoagulants or corticosteroids.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br>paracetamol 1g (500mg x2) four times daily for 14 day period | Drug: Paracetamol<br> <br> * Other names: Acetaminophen;|
| Placebo Comparator: Placebo<br>Matched placebo control: hard gelatin placebo capsules containing Lactose Ph Eur. Taken for 14 days | Drug: Placebo oral capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic ambulatory blood pressure | Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo treated groups. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic clinic blood pressure | Difference in systolic clinic BP between the paracetamol and placebo treated groups. | 14 days | 
| Diastolic ambulatory blood pressure | Difference in mean daytime diastolic ambulatory BP between the paracetamol and placebo treated groups. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood pressure, Hypertension, Paracetamol, Acetaminophen