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NCT06917729Not yet recruiting

Breathing Exercises of CardioBreath Application on Autonomic and Vascular Function in Hypertension

Responses on Arterial Stiffness and Cardiac Vagal Modulation to Breathing Exercises Through the Use of CardioBreath Application in Hypertension and Pre Hypertension; a Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Hypertension is one of the greatest public health challenges, affecting more than one billion people worldwide and representing a significant financial and public health burden. It is responsible for a high number of cardiovascular events, such as heart attacks and strokes. Although pharmacological treatment is effective, non-pharmacological interventions are essential for the sustainable management of blood pressure, especially in its early stages. Respiratory exercises have shown potential in reducing blood pressure and improving cardiac vagal modulation, promoting cardiovascular health benefits. This study aims to evaluate the effectiveness of guided respiratory exercises using the CardioBreath app in improving vagal modulation and reducing arterial stiffness in adults with prehypertension or hypertension over six weeks. This is a randomized clinical trial involving adults with prehypertension or hypertension, divided into intervention and control groups. The intervention group will use CardioBreath to perform daily breathing exercises, with weekly remote monitoring. Assessments will include heart rate variability parameters, baroreflex sensitivity, pulse wave velocity, and quality of life. It is expected that the use of the app will significantly improve vagal modulation and arterial stiffness, demonstrating the potential of this intervention for the non-pharmacological management of hypertension. The use of CardioBreath may offer an accessible and effective alternative for blood pressure control, with the potential to be integrated into public health programs focused on low-cost, highly accessible interventions for the prevention and management of hypertension.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
66 (estimated)
First submitted
18 Mar 2025
Start date
1 Aug 2025
Primary completion date
20 Jul 2027
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
NCT number
NCT06917729

What you commit to

  • Study type: Interventional
  • Planned participants: 66
  • From 1 Aug 2025 to the primary completion date, 20 Jul 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • drugs that depress the central nervous system

Other illness

  • clinical conditions that prevent participation after evaluation by the team

Other

  • use of beta-blockers
  • individuals without a cell phone or tablet (which would make the proposed study unfeasible

Who the study is looking for

  • BP>130mmHg X 80mmHg or previous medical diagnosis of pre- hypertension or hypertension

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Instituto de Cardiologia do Rio Grande do Sul
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Instituto de Cardiologia do RioGrande do Sul
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.