Resistant HypertensionTRYCORTNCT05087940
Treatment of Resistant Hypertension: Cohort Study
An observational study of Resistant Hypertension, run by Galenika AD Beograd at 12 sites in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Add-on therapy
- How many people
- 731 participants
- Where
- 12 sitesSerbia
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Serbia12 sites
Clinical Center of Serbia
Belgrade
Clinical Hospital Center Zemun
Belgrade
Clinical Hospital Center Zvezdara
Belgrade
Medical Military Academy
Belgrade
University Clinical Hospital Center Dragisa Misovic - site 1
Belgrade
University Clinical Hospital Center Dragisa Misovic - site 2
Belgrade
University Hospital Medical Center Bezanijska Kosa
Belgrade
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz
University Clinical Center Kragujevac
Kragujevac
General Hospital Leskovac
Leskovac
Clinical Center Nis
Niš
General Hospital Subotica
Subotica
About this study
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.
Read the 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
- Being tested
- Add-on therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Add-on therapyDrug
Also called 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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Add-on therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months
Adverse events rate
Incidence of adverse events
Measured: 6 months
Treatment withdrawal rate
Tolerability
Measured: 6 months
Secondary outcomes (3)
Blood pressure
Absolute value of arterial blood pressure at scheduled study visits
Measured: 6 months
Renal function
Parameters of renal function - serum level of creatinine and absolute value of proteinuria
Measured: 6 months
Quality of life on a scale 0 to 1
Quality of life at a visual analogue scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galenika AD Beograd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicinsko društvo za racionalnu terapiju Republike Srbije (MEDRAT)
- Responsible party
- Principal investigator, Slobodan Jankovic, Galenika AD Beograd
- Investigators
- Branko Andjelkovic, MD, Study director, GALENIKASlobodan Jankovic, DSc, MD, Principal investigator, University of Kragujevac, Faculty of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087940
- Sponsor's protocol ID
- TRYCORT 1.1
- Acronym
- TRYCORT
- Status last verified
- Feb 2023
- First submitted
- 12 Oct 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Resistant Hypertension: Cohort Study
- ClinicalTrials.gov ID
- NCT05087940
- Acronym / sponsor ID
- TRYCORT / TRYCORT 1.1
- Conditions
- Resistant Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Galenika AD BeogradIndustry (pharma, biotech, devices)
- Collaborators
- Medicinsko društvo za racionalnu terapiju Republike Srbije (MEDRAT)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant hypertension | – | Drug: Add-on therapyThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Add-on therapyAlso: 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 blockerAdd-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 | Drug | Resistant hypertension |
Primary outcome
Rate of normalization of arterial blood pressure
Time frame: 6 months
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
Rate of reduction of systolic arterial blood pressure
Time frame: 6 months
Reduction of systolic arterial blood pressure for 10 mmHg or more after 1,2,3,4,5 and 6 months
Rate of reduction of diastolic arterial blood pressure
Time frame: 6 months
Reduction of diastolic arterial blood pressure for 5 mmHg or more after 1,2,3,4,5 and 6 months
Adverse events rate
Time frame: 6 months
Incidence of adverse events
Treatment withdrawal rate
Time frame: 6 months
Tolerability
3 secondary outcomes
Blood pressure
Time frame: 6 months
Renal function
Time frame: 6 months
Quality of life on a scale 0 to 1
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Branko Andjelkovic, MD study director
GALENIKA
Slobodan Jankovic, DSc, MD principal investigator
University of Kragujevac, Faculty of Medical Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistant Hypertension, run by Galenika AD Beograd at 12 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of normalization of arterial blood pressure (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.