Treatment of Resistant Hypertension: Cohort Study

NCT05087940 | Completed

• 1 other identifier: TRYCORT 1.1
• Study Type: observational
• Target: 731
• Locations: 1 country
• Sites: 12

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.

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Adverse events rate

  Incidence of adverse events

  6 months

• Treatment withdrawal rate

  Tolerability

  6 months

Secondary Outcomes (3)

• Blood pressure

  6 months

• Renal function

  6 months

• Quality of life on a scale 0 to 1

  6 months

Study Arms (1)

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.

Drug: Add-on therapy

Interventions

Add-on therapy 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

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

Resistant hypertension

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Provision of signed and dated informed consent form
• 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
• Aged 18 years or above
• 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)

You may not qualify if:

• Pregnancy, anticipated pregnancy, or breastfeeding
• Incarceration or institutionalized living which may prohibit measurement of home blood pressure
• Participation in another intervention study that may affect blood pressure
• Patients in whom systolic blood pressure is not measurable (e.g. those with left ventricular assist devices)
• Hypotension: average systolic blood pressure \<100 mmHg over last 2 weeks prior to screening while not taking any blood pressure medications
• Life expectancy \<4 months
• Anticipated living donor kidney transplant within 4 months
• Patients with a systolic blood pressure value over 220 mmHg requiring immediate adjustments of therapy
• Patients with moderate to severe renal insufficiency (acute or chronic) with glomerular filtration rate of less than 30 ml/min
• Patients with active bronchospastic disorders
• Heart failure classes III and IV
• Severe bradycardia (heart rate below 50/min), 2nd and 3rd degree AV block
• Patients with a history of hypersensitivity to any of the drugs under study
• Patients already using add-on therapy

Sponsors & Collaborators

• Galenika AD Beograd: lead
• Medicinsko društvo za racionalnu terapiju Republike Srbije (MEDRAT): collaborator

Study Sites (12)

Clinical Center of Serbia

Belgrade, Serbia

Location

Clinical Hospital Center Zemun

Belgrade, Serbia

Location

Clinical Hospital Center Zvezdara

Belgrade, Serbia

Location

Medical Military Academy

Belgrade, Serbia

Location

University Clinical Hospital Center Dragisa Misovic - site 1

Belgrade, Serbia

Location

University Clinical Hospital Center Dragisa Misovic - site 2

Belgrade, Serbia

Location

University Hospital Medical Center Bezanijska Kosa

Belgrade, Serbia

Location

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, Serbia

Location

General Hospital Leskovac

Leskovac, Serbia

Location

Clinical Center Nis

Niš, Serbia

Location

General Hospital Subotica

Subotica, Serbia

Location

Study Officials

• Branko Andjelkovic, MD

  GALENIKA

  STUDY DIRECTOR

• Slobodan Jankovic, DSc, MD

  University of Kragujevac, Faculty of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 21, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (12)