Treatment of Resistant Hypertension: Cohort Study

NCT ID: NCT05087940

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 731 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Resistant Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Resistant hypertension

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.

Add-on therapy

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicinsko društvo za racionalnu terapiju Republike Srbije (MEDRAT)

UNKNOWN

Sponsor Role: collaborator

Galenika AD Beograd

INDUSTRY

Sponsor Role: lead

Responsible Party

Slobodan Jankovic

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Branko Andjelkovic, MD

Role: STUDY_DIRECTOR

GALENIKA

Slobodan Jankovic, DSc, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kragujevac, Faculty of Medical Sciences

Locations

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

Clinical Center Nis

Niš, , Serbia

General Hospital Subotica

Subotica, , Serbia

Countries

Serbia

Other Identifiers

TRYCORT 1.1

Identifier Type: -

Identifier Source: org_study_id