Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing (ROSA)

Jesper Norgaard Bech

Status: Completed

Conditions: Obstructive Sleep Apnea of Adult; Sodium Imbalance; Nocturnal Blood Pressure

Treatments: Behavioral: Dietary sodium restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT06022133

1-10-72-253-17 (Other Identifier)

BGH-5-2017

Details and patient eligibility

About

A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.

Full description

A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease. Patients with hypertension resistant of antihypertensive treatment have a high frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal pauses in breathing in this patients population.

Enrollment: 16 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 24h blood pressure > 130/80 mmHg under antihypertensive treatment with three agent, one of these being diuretic. Blood pressure measurement completed after observed intake of antihypertensive medication.
• unchanged antihypertensive treatment for three months
• estimated glomerular function >45 mL/min/1.73 m2

Exclusion criteria

• Heart failure assessed from NYHA classification (grade 3-4)
• Presence of clinically significant peripheral edema
• In treatment for obstructive sleep apnea
• Chronic obstructive pulmonary disease (FEV1 <50%)
• Antihypertensive therapy that can not be taken once daily
• Pregnancy or breastfeeding
• Β-albumin <34 g / l
• U-albumin creatinine ratio> 1000 mg / g
• INR> 1.2 (if marevan treatment: ALAT> 200)
• Gluten allergy (dietary guidelines are not adjusted to this group)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Dietary sodium restriction

Experimental group

Description:

DIetary sodium restriction

Treatment:

Behavioral: Dietary sodium restriction

Usual diet

No Intervention group

Description:

Usual diet