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 volunteersQualifiers
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
Single group
Treatments tested in this trial
sauna session
Behavioralthrice-weekly, 30-minute sauna session for 2 weeks
Treatment groups
Trial outcomes
Primary outcomes
approach-to-consent ratio
Calculated ratio of subjects approached for recruitment vs number agreed to participate
Mean monthly enrolment rate
Number of subjects enrolled per month from study opening
Drop out rate
Percentage of subjects who do not complete the 7 week sauna study after enrolment.
HILO BP monitor wearability
Number of hours of data recorded showing % of time the HILO monitor was worn during the 7 week study.
Secondary outcomes
24 hour mean blood pressure
24 hour mean blood pressure from HILO monitoring data
Daytime mean blood pressure
Daytime (0700-2300) mean BP from HILO monitor
Nighttime mean blood pressure
Mean BP (2300-0700) from HILO BP monitor device
Locations
Sponsors and contacts
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