Treatment Hypertension to Recommended Levels in Old Patients

NCT06865846 | Enrolling By Invitation DMC

• 1 other identifier: THReshOld2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

After checking the patient characteristics to the inclusion and exclusion criteria, and confirming the ability to complete the questionnaires provided by the study protocol, patients will be randomly assigned to 2 groups: a group with a higher target BP level (less than 135 mmHg) and a lower target BP level (less than 125 mmHg). Achievement of target BP levels will be assessed using a remote monitoring system. The study will identify factors that prevent achievement of target BP levels, as well as assess the efficacy, safety and tolerability of antihypertensive therapy (AHT).

Conditions

Arterial Hypertension

Keywords

arterial hypertension; remote monitoring; mHealth; telemedicine; geriatric; elderly people

Outcome Measures

Primary Outcomes (1)

• Achievement of recommended target BP level

  Achievement of recommended target BP level

  1 month

Secondary Outcomes (1)

• Assessment of the frequency of hypotensive episodes and the occurrence of hypotensive symptoms

  3 months

Study Arms (2)

BP <135

EXPERIMENTAL

Higher target BP group (less than 135 mmHg). Achievement of target BP, assessment of symptoms and frequency of hypotensive episodes will be assessed.

Device: TeleMedBot

BP <125

EXPERIMENTAL

Higher target BP group (less than 125 mmHg). Achievement of target BP, assessment of symptoms and frequency of hypotensive episodes will be assessed.

Device: TeleMedBot

Interventions

TeleMedBot DEVICE

The patient will receive a questionnaire daily containing a list of questions about blood pressure and heart rate. For this purpose, a messaging application will be installed on the patients' smartphones before the study begins. All patients will be instructed and trained to use the application. Every day at 12 noon, patients will receive a questionnaire containing 2 questions. Patients can start, pause, and continue answering for 12 hours before the next questionnaire appears. For security reasons, no personal data of patients is entered or saved in the program. The research physician will receive daily information about the patient's self-monitoring results and make decisions about the need to adjust therapy.

BP <125; BP <135

Eligibility Criteria

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

You may qualify if:

• Men and women aged 65 years and older with hypertension previously diagnosed based on repeated measurements in a medical institution.

You may not qualify if:

• Diagnosed dementia or severe cognitive impairment.
• Inability to fill in questionnaires specified in the study protocol.
• Inability to use automatic devices for recording blood pressure at home.
• Inability to use electronic devices required for remote monitoring of home blood pressure measurements and patient well-being.
• Presence of hemodynamically significant valvular heart defects.
• Presence of severe renal impairment (eGFR \<30 ml/min/1.73 m2) and/or increased blood creatinine levels to 221 μmol
• Myocardial infarction or stroke within the previous 6 months.
• Chronic heart failure with EF ≤ 40%.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead
• Russian Gerontological Scientific and Clinical Center: collaborator
• Pirogov Russian National Research Medical University: collaborator

Study Sites (1)

I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), University Clinical Hospital No.1, Russian Gerontological Scientific and Clinical Center

Moscow, Russia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sergey Gilyarevskiy, PhD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)