Treatment of Resistant Hypertension: Cohort Study

Resistant Hypertension Clinical Trial

— TRYCORT  

Official title:

Treatment of Resistant Hypertension: Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087940
• Other study ID #: TRYCORT 1.1
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Galenika AD Beograd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Resistant hypertension 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) (or beta blocker). 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

3. Aged 18 years or above

4. Inadequate control of hypertension is confirmed with home blood pressure monitoring (average of morning and evening measurements after 5 minutes of relaxation in sitting position, for 6 days)

Exclusion Criteria:

1. Pregnancy, anticipated pregnancy, or breastfeeding

2. Incarceration or institutionalized living which may prohibit measurement of home blood pressure

3. Participation in another intervention study that may affect blood pressure

4. Patients in whom systolic blood pressure is not measurable (e.g. those with left ventricular assist devices)

5. Hypotension: average systolic blood pressure <100 mmHg over last 2 weeks prior to screening while not taking any blood pressure medications

6. Life expectancy <4 months

7. Anticipated living donor kidney transplant within 4 months

8. Patients with a systolic blood pressure value over 220 mmHg requiring immediate adjustments of therapy

9. Patients with moderate to severe renal insufficiency (acute or chronic) with glomerular filtration rate of less than 30 ml/min

10. Patients with active bronchospastic disorders

11. Heart failure classes III and IV

12. Severe bradycardia (heart rate below 50/min), 2nd and 3rd degree AV block

13. Patients with a history of hypersensitivity to any of the drugs under study

14. Patients already using add-on therapy

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

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

Locations

Country	Name	City	State
Serbia	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	University Clinical Center Kragujevac	Kragujevac
Serbia	General Hospital Leskovac	Leskovac
Serbia	Clinical Center Nis	Niš
Serbia	Institute of Cardiovascular Diseases of Vojvodina	Sremska Kamenica
Serbia	General Hospital Subotica	Subotica

Sponsors (2)

Lead Sponsor	Collaborator
Galenika AD Beograd	Medicinsko društvo za racionalnu terapiju Republike Srbije (MEDRAT)

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 months
Primary	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	6 months
Primary	Adverse events rate	Incidence of adverse events	6 months
Primary	Treatment withdrawal rate	Tolerability	6 months
Secondary	Blood pressure	Absolute value of arterial blood pressure at scheduled study visits	6 months
Secondary	Renal function	Parameters of renal function - serum level of creatinine and absolute value of proteinuria	6 months
Secondary	Quality of life on a scale 0 to 1	Quality of life at a visual analogue scale	6 months