Clinical trial NCT07018128: Expression of Genes Relating Hypertension and Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure
Official title: Expression of Genes Relating Hypertension in Thailand and the Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure in Individuals With Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genetic Predisposition to Disease
Breathing, Mouth
Keywords: Gene
Blood pressure
Breathing
Lead sponsor: Burapha University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study 1 is a cross-sectional study model and study 2 is an experimental study model.
Primary purpose: BASIC_SCIENCE

Brief summary: This study consists of two sub-studies. Study 1 investigates gene expression related to the development of hypertension in Thailand, and Study 2 examines the effectiveness of the 4-7-8 breathing technique in reducing blood pressure in individuals with hypertension.

Detailed description: In Study 1, the sample group includes 200 individuals aged 18-59 years, originating from various regions of Thailand but currently residing in the eastern region. Participants may have normal blood pressure, high blood pressure, or have been diagnosed with hypertension. Blood samples from the participants will be analyzed for the following variables: 1) expression of five genes-adrenomedullin (ADM), angiopoietin-like 4 (ANGPTL4), proto-oncogene c-Fos (FOS), prostaglandin-endoperoxide synthase 2 (PTGS2), and ubiquitin specific peptidase 8 (USP8), and 2) markers of inflammation-tumor necrosis factor-alpha and interferon-gamma levels in the blood.

In Study 2, the sample group includes 75 volunteers from Study 1 who are interested in participating. These volunteers will be randomly assigned into three groups of 25 people each. The first group is a control group whose participants will not receive any breathing training. The second group will practice the 4-7-8 breathing technique, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds-this constitutes one cycle. They will repeat this for 6 cycles per set, three sets per day, with normal breathing between sets. The third group will practice deep diaphragmatic breathing at a rate of 6-10 breaths per minute for 15 minutes, twice a day. Participants in both the second and third groups are required to follow their assigned breathing programs daily for three consecutive months. At the end of the three months, all participants will be assessed on the same variables measured before the intervention: 1) systolic and diastolic blood pressure levels, 2) blood pressure variability, and 3) inflammation markers, specifically tumor necrosis factor-alpha and interferon-gamma levels in the blood.

Eligibility criteria: Study 1:

1. Group of individuals with hypertension

   Inclusion Criteria:
   * Male or female
   * Aged between 18-59 years
   * Of Thai ethnicity
   * Diagnosed with hypertension, defined as having an SBP of 140 mmHg or higher, or a DBP of 90 mmHg or higher, or having previously been diagnosed with hypertension and currently taking antihypertensive medication
   * Originally from various regions of Thailand and currently residing in the eastern region

   Exclusion Criteria:
   * Has heart disease, such as valvular stenosis or regurgitation, coronary artery disease, or heart failure
   * Has obesity, defined as having a body mass index (BMI) of 30 kg/m² or higher
   * Has a fever or is currently experiencing an infectious disease, such as COVID-19, the flu, or other infections
2. Group of individuals with normal blood pressure

Inclusion Criteria:

* Male or female
* Aged between 18-59 years
* Of Thai ethnicity
* Does not have hypertension, defined as having an SBP below 130 mmHg and a DBP below 85 mmHg, with no prior diagnosis of hypertension and no history of taking antihypertensive medication
* Originally from various regions of Thailand and currently residing in the eastern region

Exclusion Criteria:

* Has heart disease, such as valvular stenosis or regurgitation, coronary artery disease, or heart failure
* Has obesity, defined as having a body mass index (BMI) of 30 kg/m² or higher
* Has a fever or is currently experiencing an infectious disease, such as COVID-19, the flu, or other infections

Study 2:

Inclusion Criteria:

* Male or female, aged 35-59 years
* Diagnosed with hypertension, with blood pressure levels above the normal range, defined as SBP of 130 mmHg or higher, or DBP of 85 mmHg or higher, and currently taking medication
* Originally from various regions of Thailand and currently residing in the eastern region
* Able to communicate effectively

Exclusion Criteria:

* Has respiratory diseases, cardiovascular diseases, cerebrovascular disease, kidney disease, cancer, or immune-related conditions such as allergies, autoimmune diseases (e.g., SLE), immunodeficiency, or rheumatoid arthritis
* Is obese, defined as having a body mass index (BMI) of 30 kg/m² or higher
* Has a fever or is currently infected, such as with COVID-19, the flu, or other infectious diseases
* Is currently pregnant, breastfeeding, or has a history of pregnancy within the 6 months prior to participating in the study

Primary outcomes:
measure: Study 1: expression of adrenomedullin (ADM)
timeFrame: Day 1
measure: Study 1: expression of angiopoietin-like 4 (ANGPTL4)
timeFrame: Day 1
measure: Study 1: expression of proto-oncogene c-Fos (FOS)
timeFrame: Day 1
measure: Study 1: expression of prostaglandin-endoperoxide synthase 2 (PTGS2)
timeFrame: Day 1
measure: Study 1: expression of ubiquitin specific peptidase 8 (USP8)
timeFrame: Day 1
measure: Study 1: tumor necrosis factor-alpha
timeFrame: Day 1
measure: Study 1: interferon-gamma
timeFrame: Day 1
measure: Study 2: systolic blood pressure
timeFrame: Day 1 and Day 85
measure: Study 2: diastolic blood pressure
timeFrame: Day 1 and Day 85
measure: Study 2: systolic blood pressure coefficient of variation
timeFrame: Day 1 and Day 85
measure: Study 2: diastolic blood pressure coefficient of variation
timeFrame: Day 1 and Day 85
measure: Study 2: tumor necrosis factor-alpha
timeFrame: Day 1 and Day 85
measure: Study 2: interferon-gamma
timeFrame: Day 1 and Day 85
Secondary outcomes:
Other outcomes:
Locations:
city: MueangChonburi
country: Thailand
facility: Faculty of Allied Health Sciences, Burapha University
state: Chonburi
Study officials:
References: