Regular Sauna Use to Lower Blood Pressure in Primary Aldosteronism

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Calgary

About this trial

1. Background and Rationale: Primary aldosteronism is a hypertension-related disorder where salt restriction/salt loss is a central part of therapy. Dietary salt restriction to sufficient degree is very difficult for most patients and thus medications are frequently required to control blood pressure. Non-pharmacologic means of reducing total body sodium and blood pressure are required and desired by patients. Sauna bathing is a traditional wellness practice associated with extensive sweating and therefore salt loss. We wish to study whether incorporation of sauna bathing into a treatment plan for primary aldosteronism might lower blood pressure without increased medications. A pilot feasibility study is required prior to design of a larger controlled clinical trial. We are looking to conduct a short term simulated sauna study to assess patient acceptability and study feasibility as the primary outcomes. 2. Research Questions and Objectives: This study will test the feasibility of having patients add regular sauna usage to their weekly lifestyle, while being treated for hypertension due to primary aldosteronism. The primary objective will be to assess patient recruitment rates, subject retention, patient acceptability, and patient adherence to regular sauna intervention during a 2-week period, using an a priori "traffic light" decision matrix. The secondary objectives will be to explore change in blood pressure, as measured by a wearable, continuous BP wrist monitor, before and after a 2 week sauna intervention. 3. Methods: The study will occur in the context of routine ongoing care in the Endocrine Hypertension Clinic. Ten patients with primary aldosteronism will be recruited to a 7 week study where we will observe the feasibility and acceptability of wearing a continuous, cuffless, wrist BP monitoring device for 2-week periods prior to, during, and after a 2 week "sauna" therapy program. The sauna therapy will consist of three 30 minute visits to a commercially licensed and insured local sauna club each week for 2 weeks. Standardized subject experience questionnaires will collect feasibility and acceptability data which will be analyzed with a standard red light/yellow light/green light approach to study feasibility conclusions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a) Age 18-65 b) Hypertension with PA diagnosed using Endocrine Society's 2025 criteria c) Stable medical therapy with no change in dose/agent in prior 6 weeks d) BP uncontrolled, clinic > 140/90 or ABPM mean > 135/85 e) Dietary sodium moderate or higher (> 128 mmol/d) f) Subject owns iPhone (12-16) or Android and willing to install HiLo app

Disqualifiers

BP > 160/105 in clinic or > 155/100 on ABPM

Planning adrenalectomy or other surgery during trial

Recent hospitalization for any reason, in the past 3 months

Confirmed or suspected MI, angina, CHF or arrhythmia diagnosis in the past 6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • sauna session

    Behavioral

    thrice-weekly, 30-minute sauna session for 2 weeks

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Sauna interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

approach-to-consent ratio

Calculated ratio of subjects approached for recruitment vs number agreed to participate

Time frame
from study initiation to end of recruitment window 52 weeks later
2

Mean monthly enrolment rate

Number of subjects enrolled per month from study opening

Time frame
within 6 months of study initiation
3

Drop out rate

Percentage of subjects who do not complete the 7 week sauna study after enrolment.

Time frame
from subject enrolment to intervention completion 7 weeks later.
4

HILO BP monitor wearability

Number of hours of data recorded showing % of time the HILO monitor was worn during the 7 week study.

Time frame
From enrolment to intervention completion, 7 weeks.

Secondary outcomes

1

24 hour mean blood pressure

24 hour mean blood pressure from HILO monitoring data

Time frame
3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
2

Daytime mean blood pressure

Daytime (0700-2300) mean BP from HILO monitor

Time frame
3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.
3

Nighttime mean blood pressure

Mean BP (2300-0700) from HILO BP monitor device

Time frame
3 time frames: first two weeks of run-in, two weeks of intervention, two weeks of run-out.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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