NCT07049289

Brief Summary

Prospective, randomized trial to assess the effects of a telemedical approach of antihypertensive treatment in comparison with standard care. Total patient number: 60 patients.

  • Intervention group: biweekly telephone calls
  • Control group: standard of care

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 25, 2025

Last Update Submit

June 25, 2025

Conditions

Arterial HypertensionUncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

  • Time in blood pressure target range from randomization through 6 months

    Time in target range of each blood pressure measurement in first 6 months between control and intervention group

    6 months

Secondary Outcomes (2)

  • Time in target range months 6 to 12

    6 months (7-12 months)

  • Medication adherence as assessed by blood/urine sampling after 6 and 12 months

    0, 6 and 12 months

Study Arms (2)

Control

NO INTERVENTION

Patients with arterial hypertension randomized to control arm with standard of care without additional interference through study team

Telemedical treatment

EXPERIMENTAL

Patients randomized to intervention group will receive biweeky telephone calls and adaption of antiyhpertensive medication if needed

Other: Telemonitoring

Interventions

TelemonitoringOTHER

Patients randomized to intervention group will receive biweeky telephone calls and adaption of antiyhpertensive medication if needed

Also known as: telemedicine
Telemedical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed arterial hypertension with systolic or diastolic blood pressure \>140/90 mmHg in standardized office blood pressure measurement
  • Treatment with 1 to ≤4 antihypertensive drug classes
  • Age \>18 years
  • Written informed consent

You may not qualify if:

  • Pregnancy
  • Participation in other randomized trials
  • Patients under legal supervision or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Centre Leipzig

Leipzig, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

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

June 25, 2025

First Posted

July 3, 2025

Study Start

December 13, 2023

Primary Completion

March 9, 2025

Study Completion

September 9, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations

DE(1)