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This is a multicenter, prospective observational cohort study. It will compare effectiveness and safety of various add-on treatment options in regard to arterial blood pressure control in adult patients with treatment resistant hypertension: an aldosterone receptor blocker (e.g. spironolactone), a loop diuretic, a thiazide in large daily dose, an alpha 1 selective blocker or a beta 1 selective blocker. The add-on therapy will be prescribed to the patients within the scope of their routine medical care, independently from the study investigators. The patients will be followed up for 6 months, with monthly visits and continuous home blood pressure diary kept by the patients themselves.
This is a multicenter, prospective observational cohort study. It will compare effectiveness and safety of various add-on treatment options in regard to arterial blood pressure control in adult patients with treatment resistant hypertension: an aldosterone receptor blocker (e.g. spironolactone), a loop diuretic, a thiazide in large daily dose, an alpha 1 selective blocker or a beta 1 selective blocker. The add-on therapy will be prescribed to the patients within the scope of their routine medical care, independently from the study investigators. Both office and home blood pressure measures will be recorded at baseline and then every month for 6 visits. The systolic and diastolic blood pressure targets are chosen according to European guidelines for treatment of hypertension, i.e. \< 140/90 mmHg. Participants will have contact with the study team at any time to obtain information on interim study outcomes (updated medical history, completion of study questionnaires). Before, during and after the study the patients will be cared for by their chosen general practitioners independently from the study investigators and referred to internal medicine specialists as necessary, according to diagnostic and treatment protocols currently in power at the study sites. Role of the study investigators will be limited to observation and collection of data from the patients themselves and from their medical files.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Clinical Center of Serbia
Belgrade, Serbia
Clinical Hospital Center Zemun
Belgrade, Serbia
Clinical Hospital Center Zvezdara
Belgrade, Serbia
Medical Military Academy
Belgrade, Serbia
University Clinical Hospital Center Dragisa Misovic - site 1
Belgrade, Serbia
University Clinical Hospital Center Dragisa Misovic - site 2
Belgrade, Serbia
University Hospital Medical Center Bezanijska Kosa
Belgrade, Serbia
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia
General Hospital Leskovac
Leskovac, Serbia
Start Date
June 1, 2021
Primary Completion Date
December 31, 2022
Completion Date
December 31, 2022
Last Updated
February 22, 2023
731
ACTUAL participants
Add-on therapy
DRUG
Lead Sponsor
Galenika AD Beograd
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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