Telmisartan for high blood pressure
| ISRCTN | ISRCTN54936745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54936745 |
| Secondary identifying numbers | DRL_RUS/PMS/2017/TEL |
- Submission date
- 07/12/2020
- Registration date
- 15/03/2021
- Last edited
- 15/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Background and study aims
Many people around the globe suffer from hypertension (high blood pressure). In fact, hypertension is one of the leading causes of illness and death in the world. Moreover, hypertension increases the risk of acute cardiovascular events such as stroke or myocardial infarction (heart attack). One of the main ways to control hypertension is medication. One such medication is telmisartan, which was extensively studied in clinical trials. Nevertheless, clinical trials involve certain groups of patients while the physician was under thorough control of telmisartan use. For that reason, the researchers aim to study telmisartan use in the routine practice of physicians to evaluate its effectiveness against hypertension in real-world conditions.
Who could participate?
Adults aged over 18 who have high blood pressure and have been prescribed telmisartan alone or in combination with hydrochlorothiazide/amlodipine before enrollment.
Wha did the study involve?
Patients are enrolled in the study when the physician decides to prescribe telmisartan or telmisartan with hydrochlorothiazide or telmisartan in combination with amlodipine. Participation in the study does not influence the investigator’s decision on treatment choice. After the start of the treatment, patients measure their blood pressure daily and complete diaries. Moreover, data on any adverse events are also collected in order to evaluate the safety of the treatments. Patients complete the diaries across a 12-week period that allows the investigators to monitor blood pressure changes in different circumstances.
What are the possible benefits and risks of participating?
Participants do not receive a direct benefit from this study as they are receiving treatment as usual. Risks include adverse events that could develop during the study participation.
Where is the study run from?
Myasnikov's Scientific Research Institute (Russia)
When is the study starting and how long is it expected to run for?
November 2017 to April 2019
Who is funding the study?
Dr. Reddy's Laboratories LLC (Russia)
Who is the main contact?
Olga D. Ostroumova
ostroumova.olga@mail.ru
Contact information
Prof Olga Ostroumova
Scientific
Scientific
Bolshaya Pirogovskaya st., 2 b. 4
Moscow
119435
Russian Federation
 ORCID ID |
0000-0002-0795-8225 |
|---|---|
| Phone | +7 (499) 248 -75-44 |
| ostroumova.olga@mail.ru |
Study information
| Study design | Cross-sectional observational prospective multicenter study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Telmisartan for the INitiation and maintenance of Antihypertensive treatment: a cross-sectional pharmacoepidemiology and prospective observational study in Russia |
| Study acronym | TAINA |
| Study objectives | Data from 2,000 individuals who start their drug therapy for arterial hypertension by taking telsartan or telsartan H in the therapeutically recommended dose range for 12 weeks will be used to examine the real-world effectiveness and safety of telsartan and telsartan H, especially taking into account that current guidelines reconfirm that diuretics, beta-blockers, calcium antagonists, angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers are all suitable for the initiation and maintenance of antihypertensive treatment, either as monotherapy or in some combinations. |
| Ethics approval(s) | Approved 15/12/2017, Independent interdisciplinary ethical committee (125468, Leningrandsky prospect, 51, Moscow, Russian Federation; +7 (0)9153463030; beresneva.sofia@gmail.com), ref: #20 |
| Health condition(s) or problem(s) studied | Arterial hypertension |
| Intervention | Data from 2,000 individuals who start their drug therapy for arterial hypertension by taking telsartan or telsartan H in the therapeutically recommended dose range for 12 weeks will be used to examine the effectiveness and safety of telsartan and telsartan H as monotherapy or in combination with hydrochlorothiazide/amlodipine in a real-world setting. Patients are followed-up for 12 weeks after enrollment. During the course of the study data on self-measured blood pressure is obtained by physicians from patients. Additionally, patients fill in EQ-5D quality of life forms, and data on symptoms of hypertension and adverse events are collected. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Telmisartan, hydrochlorthiazide, amlodipine |
| Primary outcome measure | 1. Demographic, lifestyle and clinical characteristics: 1.1. BMI kg/m² data obtained from source documents at Visit 1 1.2. Status of smoking measured using medical history data in source documents and information obtained from the patient at Visit 1 1.3. Alcohol consumption measured using medical history data in source documents and information obtained from the patient at Visit 1 1.4. Sedentary lifestyle measured using medical information obtained from the patient at Visit 1 1.5. Cardiovascular risk measured using SCORE assessment at Visit 1 2. Patient self-measurement of blood pressure using home blood pressure monitoring (HBPM) from baseline to endpoint 3. Office blood pressure measurement by medical personnel from baseline to endpoint |
| Secondary outcome measures | 1. Tolerability of the therapy measured as the number of patients with adverse reactions and the incidence of different adverse reactions at 12 weeks 2. Course of hypertension-induced renal damage by assessing the following after 12 weeks of treatment: 2.1. Creatinine blood level 2.2. Estimated glomerular filtration rate (eGFR) 2.3. Urinary excretion of albumin 3. Rate (%) of adherence to the initial treatment measured using patient self-report at 12 weeks 4. In the subpopulation reporting headache at baseline, headache symptoms measured using the headache inventory at baseline and 12 weeks 5. Number of patients with controlled AH (continuous maintenance of target blood pressure according to 2013 ESC guidelines) at 12 weeks 6. Patients’ satisfaction with their treatment as measured by patient diary at baseline and the end of 12 weeks of telmisartan treatment 7. Health-related quality of life (HRQOL) measured at baseline and 12 weeks by: 7.1. SF-36 Health Survey summary 7.2. Likert scale score assessing the changes in patient's daily life |
| Overall study start date | 29/11/2017 |
| Completion date | 15/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2,200 |
| Total final enrolment | 1999 |
| Key inclusion criteria | 1. ICF signed prior to enrollment 2. Hypertension diagnosis verified 3. Office SBP >140 mmHg and/or office DBP >90 mmHg 4. Absence or inefficacy of antihypertensive treatment prior to enrollment 5. Decision of telmisartan prescription as monotherapy or in combination with hydrochlorothiazide/amlodipine was taken by the physician prior to enrollment |
| Key exclusion criteria | 1. Telmisartan treatment during 90 days prior to enrollment 2. Malignant hypertension 3. Secondary hypertension 4. Refuse to monitor BP by patient 5. Pregnancy and lactation period 6. Any condition that could alter patient safety or protocol procedures during the course of study 7. Any condition that by physician’s decision could stop from patient enrollment 8. Hypersensitivity, significant ADRs or contraindications for telmisartan treatment 9. Refusal to follow the physician’s instructions |
| Date of first enrolment | 26/12/2017 |
| Date of final enrolment | 27/03/2019 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Myasnikov's Scientific Research Institute
3-ya Cherepkovskaya st., 15a
Moscow
121552
Russian Federation
Moscow
121552
Russian Federation
City clinical hospital 29 for N.E. Bauman
Budenny av., 37/1
Moscow
105275
Russian Federation
Moscow
105275
Russian Federation
City clinical hospital 29 for M.E. Jadkevitch
Mozhayskoye highway, 14
Moscow
121374
Russian Federation
Moscow
121374
Russian Federation
Moscow county scientific research institute for M.F. Vladimirsky
Schepkina st. 61/2
Moscow
129110
Russian Federation
Moscow
129110
Russian Federation
National scientific research institute of preventive medicicne
Petroverigskiy al., 10
Moscow
101990
Russian Federation
Moscow
101990
Russian Federation
Polyclinic #3
Grokholskiy al, 31
Moscow
129090
Russian Federation
Moscow
129090
Russian Federation
City clinical hospital #7
Marshala Chuikova st., 54
Kazan
420103
Russian Federation
Kazan
420103
Russian Federation
Department of hospital therapy of State Budgetary Educational Institution of Higher Education "Nizhny Novgorod State Medical Academy" based at "N.A. Semashko County Clinical Hospital"
Rodionova st., 190
Nizhny Novgorod
603093
Russian Federation
Nizhny Novgorod
603093
Russian Federation
Department of internal diseases of State Budgetary Educational Institution of Higher Education "Nizhny Novgorod State Medical Academy" based at "City Clinical Hospital #38"
Chernyshevskogo st., 22
Nizhny Novgorod
603000
Russian Federation
Nizhny Novgorod
603000
Russian Federation
Federal State Budgetary Healthcare Institution "Samara County Clinical Cardiological Dispensary"
Aerodromnaya st., 43
Samara
443070
Russian Federation
Samara
443070
Russian Federation
State Healthcare Institution "Saratov City Polyclinic #2"
Moskovskaya st., 137/149
Saratov
410012
Russian Federation
Saratov
410012
Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Bashkirian State Medical University"
Lenina st., 3
Ufa
450000
Russian Federation
Ufa
450000
Russian Federation
City Clinical Hospital #1
Vorovskogo st., 16
Chelyabinsk
454092
Russian Federation
Chelyabinsk
454092
Russian Federation
LLC "Medical Union "New Hospital"
Zavodskaya st., 29 b.3
Ekaterinburg
620109
Russian Federation
Ekaterinburg
620109
Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University"
Odesskaya st., 54
Tyumen
625023
Russian Federation
Tyumen
625023
Russian Federation
District Budgetary Healthcare Institution "Krasnoyarsk District Clinical Hospital"
Partizana Zheleznyaka st., 3a
Krasnoyarsk
660022
Russian Federation
Krasnoyarsk
660022
Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University"
Ostryakova st., 2
Vladivostok
690002
Russian Federation
Vladivostok
690002
Russian Federation
State Budgetary Healthcare Institution "Irkutsk County Clinical Hospital"
Carla Marksa st., 29
Irkutsk
664003
Russian Federation
Irkutsk
664003
Russian Federation
Federal State Budgetary Scientific Institution "Scientific Research Institute for Complex Cardiovascular Diseases Problems"
Sosnoviy bor, 6
Kemerovo
650000
Russian Federation
Kemerovo
650000
Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Krasnoyarsk State Medical University of V.F. Voyno-Yasenetskiy"
Partizana Zheleznyaka st., 1
Krasnoyarsk
660022
Russian Federation
Krasnoyarsk
660022
Russian Federation
Polyclinic #9 at State Autonomous Healthcare Institution "City Clinical Hospital #1"
Khitarova st., 32
Novokuznetsk
654027
Russian Federation
Novokuznetsk
654027
Russian Federation
State Autonomous Healthcare Institution "City Clinical Hospital #1"
Bardina st., 28
Novokuznetsk
654057
Russian Federation
Novokuznetsk
654057
Russian Federation
Federal State Budgetary Healthcare Institution "Novosibirsk County Clinical Cardiological Dispensary"
Zalesskogo st., 6/8
Novosibirsk
630047
Russian Federation
Novosibirsk
630047
Russian Federation
Federal State Budgetary Scientific Institution "Scientific Research Institute of Cardiology"
Kiyevskaya st., 111a
Tomsk
634012
Russian Federation
Tomsk
634012
Russian Federation
District Budgetary Healthcare Institution "City Polyclinic #3"
Dikopoltseva st., 34
Khabarovsk
680000
Russian Federation
Khabarovsk
680000
Russian Federation
State Budgetary Healthcare Institution "Novosibirsk State County ClinicalHospital"
Nemirovicha-Danchenko st., 130
Novosibirsk
630087
Russian Federation
Novosibirsk
630087
Russian Federation
State Budgetary Healthcare Institution Scientific Research Institute "District Clinical Hospital"
May 1st st., 167
Krasnodar
350086
Russian Federation
Krasnodar
350086
Russian Federation
Municipal Budgetary Healthcare Institution "City Emergency Care Hospital of Rostov-na-Donu"
Bodraya st., 88/35
Rostov-na-Donu
344068
Russian Federation
Rostov-na-Donu
344068
Russian Federation
State Budgetary Healthcare Institution of Republic of Crymea "Republican Clinical Hospital for N.A. Semashko"
Kiyevskaya st., 69
Simpferopol
295017
Russian Federation
Simpferopol
295017
Russian Federation
State Budgetary Healthcare Institution of Stavropol District "District Clinical Cardiological Dispensary"
Prigorodnaya st., 224a
Stavropol
355026
Russian Federation
Stavropol
355026
Russian Federation
International Medical Centre "Sogaz"
Malaya Konushennaya st., 8
Saint-Petersburg
191186
Russian Federation
Saint-Petersburg
191186
Russian Federation
Multibranch Medical Diagnostic Centra "Medsanchast #157"
Warshavskaya st., 100
Saint-Petersbutg
196066
Russian Federation
Saint-Petersbutg
196066
Russian Federation
Saint-Petersbutg State Budgetary Healthcare Institution "City Diagnostic and Consultation Centre #1"
Sikeyros st., 10a
Saint-Petersburg
194354
Russian Federation
Saint-Petersburg
194354
Russian Federation
Budgetary Healthcare Institution "Voronezh county clinical hospital".
Moskowsky prospect, 151a
Voronezh
394066
Russian Federation
Voronezh
394066
Russian Federation
County Budgetary Healthcare Institution "Voronezh City Polyclinic #5"
Zapolnaya st., 43a
Kursk
305000
Russian Federation
Kursk
305000
Russian Federation
"Therapeutic-diagnostic clinic" LLC
2-ya Kiyevskaya st., 11
Smolensk
214018
Russian Federation
Smolensk
214018
Russian Federation
Sponsor information
Dr. Reddy’s Laboratories (Russia)
Industry
Industry
Ovchinnikovskaya emb., 20 b. 1
Moscow
115035
Russian Federation
| Phone | +7 (495)783-29-01 |
|---|---|
| Anastasiya.Nasonova@drreddys.com | |
| Website | http://www.drreddys.ru/ |
Funders
Funder type
Industry
Dr. Reddy's Laboratories LLC
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Part of the study results are already published in a Russian scientific medical journal and the rest are yet to be published in an international journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to terms of an agreement between the investigators and the sponsor. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/04/2020 | 07/12/2020 | Yes | No |
| Protocol file | version v1 | 15/03/2021 | No | No |
Additional files
- ISRCTN54936745_PROTOCOL_v1.pdf
- Uploaded 15/03/2021
Editorial Notes
15/03/2021: Uploaded protocol Version 1 (not peer reviewed).
11/12/2020: Trial's existence confirmed by an independent interdisciplinary ethical committee.
