Regular Sauna Use to Lower Blood Pressure in Primary Aldosteronism

NCT07796048 | Not Yet Recruiting

• 1 other identifier: REB26-1232
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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. 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.

Conditions

Primary Aldosteronism; Hypertension

Keywords

sodium; salt; sauna; hypertension; aldosterone

Outcome Measures

Primary Outcomes (6)

• approach-to-consent ratio

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

  from study initiation to end of recruitment window 52 weeks later

• Mean monthly enrolment rate

  Number of subjects enrolled per month from study opening

  within 6 months of study initiation

• Drop out rate

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

  from subject enrolment to intervention completion 7 weeks later.

• HILO BP monitor wearability

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

  From enrolment to intervention completion, 7 weeks.

• Score on the Acceptability of Intervention Measure

  Mean score (/20) on the patient-scoring system Acceptability of Intervention Measure

  from enrolment to study intervention completion, 7 weeks.

• Sauna Usability

  Proportion of subjects attending 4 or more of the 6 scheduled sauna sessions

  2 weeks of sauna intervention phase

Secondary Outcomes (3)

• 24 hour mean blood pressure

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

• Daytime mean blood pressure

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

• Nighttime mean blood pressure

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

Study Arms (1)

Sauna intervention

EXPERIMENTAL

Feasibility of thrice-weekly sauna sessions for 2 weeks

Behavioral: sauna session

Interventions

sauna session BEHAVIORAL

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

Sauna intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• CKD, eGFR \< 30 ml/min/m2
• Pregnancy, planned pregnancy, or non-use of contraceptive during study
• Recent hypotensive event/syncope in the past 3 months
• Any complex medical condition where sauna exposure is not advised
• Planning major dietary change
• History of medication non-adherence
• Night shift worker / at work after 2000h
• Planned vacation/absence during 6-week study
• Inability to read English or consent to participation

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gregory Kline, MD

CONTACT

403-955-8327; gakline@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 31, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share