An observational study in Resistant Hypertension, sponsored by Galenika AD Beograd. Completed at 12 sites in Serbia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Galenika AD Beograd · Observational
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 731 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with Galenika AD Beograd as lead sponsor.
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Subjects with resistant hypertension (casual blood pressure during clinical examination of more than 140/90 mmHg despite treatment with optimal or best-tolerated doses of three or more drugs, which should include a diuretic, typically an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB), and a calcium channel blocker (CCB) who meet the inclusion and exclusion criteria will be eligible for participation in this study.
Exclusion Criteria:
The adult patients with resistant hypertension which is defined as casual blood pressure during clinical examination of more than 140/90 mmHg despite treatment with optimal or best-tolerated doses of three or more drugs, which should include a diuretic, typically an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB), and a calcium channel blocker (CCB). All reference blood pressures will be taken as a mean of the 2nd and 3rd measurements in physician's office during a single examination, measured at least 3 min apart. The following add-on therapy is available in Serbia, where the study is conducted: an aldosterone receptor blocker (e.g. spironolactone), a loop diuretic (e.g. furosemide), a thiazide in large daily dose, an alpha 1 selective blocker and a beta 1 selective blocker.
Drug: Add-on therapy
Add-on drugs prescribed by internal medicine specialists within the routine health care and independently from the study investigators - one of the following: an aldosterone receptor blocker, a loop diuretic, a thiazide in large daily dose, an alpha 1 selective blocker or a beta 1 selective blocker
Also known as: An aldosterone receptor blocker, or a loop diuretic, or a thiazide in large daily dose, or an alpha 1 selective blocker, or a beta 1 selective blocker
Rate of normalization of arterial blood pressure
Decrease of arterial blood pressure to normal levels according to the 2018 European Society for Cardiology (ESC)/European Society for Hypertension (ESH) Guidelines (\<140/90 mmHg) after 1,2,3,4,5 and 6 months
Time frame: 6 months
Rate of reduction of systolic arterial blood pressure
Reduction of systolic arterial blood pressure for 10 mmHg or more after 1,2,3,4,5 and 6 months
Time frame: 6 months
Rate of reduction of diastolic arterial blood pressure
Reduction of diastolic arterial blood pressure for 5 mmHg or more after 1,2,3,4,5 and 6 months
Time frame: 6 months
Adverse events rate
Incidence of adverse events
Time frame: 6 months
Treatment withdrawal rate
Tolerability
Time frame: 6 months
Blood pressure
Absolute value of arterial blood pressure at scheduled study visits
Time frame: 6 months
Renal function
Parameters of renal function - serum level of creatinine and absolute value of proteinuria
Time frame: 6 months
Quality of life on a scale 0 to 1
Quality of life at a visual analogue scale
Time frame: 6 months
Plan to share: No
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