Ischaemic Heart Disease (IHD)Phase 4NCT03856242
Benign Prostatic Hyperplasia and Ischemic Heart DIsease
A Phase 4 study testing Tamsulosin Oral Capsule and TURP in people with Ischaemic Heart Disease (IHD) and Benign Prostatic Hyperplasia (BPH), run by I.M. Sechenov First Moscow State Medical University.
Trial summary
To examine the dynamics of 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions resulted from benign prostatic hyperplasia (BPH) with the indications for either conservative or operative treatment. Read more about this study
- Who is it for?
- Ages 57 to 81 years, men only
- Conditions the study is for
- Ischaemic Heart Disease (IHD), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- Tamsulosin Oral Capsule and TURP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Sep 2017
- Phase
- Phase 4
- 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 57 to 81 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LUTS/BPH, with the total score by the IPSS more than or equal to 8;
- Functional class II-IV angina of effort;
- Non-ST segment depression postinfarction cardiosclerosis.
Who cannot join
- Presence of cystostomic drainage;
- Long-term LUTS/BPH therapy of prostatic hyperplasia (alpha-adrenoblockers, 5-alpha-reductase inhibitors and others) - for the groups of patients of conservative treatment of BPH;
- Patients after operative treatment of prostatic hyperplasia (TUR of prostatic hyperplasia, transvesical adenomectomy, etc.);
- Urinary bladder stones;
- Acute urinary retention;
- Changes on the ECG hampering its interpretation (complete left bundle branch block, cicatricial changes after endured myocardial infarction, permanent form of ciliary arrhythmia);
- Acute forms of ischaemic heart disease.
About this study
To examine the dynamics of 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions resulted from benign prostatic hyperplasia (BPH) with the indications for either conservative or operative treatment.
A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.
Read the detailed description
A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients diagnosed with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.
Depending on the results of primary Holter monitoring (HM) and the method of correction (medicamentous or operative) of LUTS/BPH, all patients were subdivided into 3 groups:
Group 1 (n=20) included patients in whom primary HM revealed ECG alterations appearing or deteriorating during urination; all these patients along with recommended cardiotropic therapy, for improving impaired urination received tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow-up and treatment.
Group 2 (n=28) was composed of patients who had Holter-detected diagnostically significant ECG alterations, however, nonrelated to the act of urination; all these patients, along with the recommended cardiac therapy, in order to improve impaired urination were also received tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow up and treatment.
Group 3 (n=35) consisted of patients with BPH and IHD found to have pronounced impairments severe obstructed urination and transurethral resection of the prostate (TURP) was performed. Like in the previous group HM demonstrated diagnostically significant changes in the ECG, not however related to the act of urination.
Criteria for inclusion into the study: 1) patient's consent; 2) absence of severe accompanying pathology hampering carrying out the study (mental disorders, musculoskeletal system diseases, oncological diseases); 3) LUTS/BPH, with the total score by the IPSS more than or equal to 8; 4) functional class II-IV angina of effort; 5) non-ST segment depression postinfarction cardiosclerosis.
Exclusion criteria: 1) presence of cystostomic drainage; 2) long-term medicamentous therapy of prostatic hyperplasia (alpha-adrenoblockers, 5-alpha-reductase inhibitors and others) - for the groups of patients of conservative treatment of BPH; 3) patients after operative treatment of prostatic hyperplasia (TUR of prostatic hyperplasia, transvesical adenomectomy, etc.); 4) urinary bladder stones; 5) acute urinary retention; 6) "paradoxical" ischuria; 7) changes on the ECG hampering its interpretation (complete left bundle branch block, cicatricial changes after endured myocardial infarction, permanent form of ciliary arrhythmia); 8) acute forms of ischaemic heart disease.
Criteria for withdrawal: voluntary refusal of the patient from further follow up;
Beside interviewing (in the presence of angina, the patients filled in the Seattle Angina Questionnaire), the patients were subjected to measuring arterial pressure on both arms, biochemical blood analysis (measuring the level of triglycerides, cholesterol, if necessary, high-, low- and very-low density lipoproteins), standard 12-lead ECG. All patients in order to verify the diagnosis of IHD underwent detailed examination in the settings of a cardiological hospital including, if required, the following studies: tread-mill, stress-echocardiography, coronarography, multispiral computed tomography of the coronary arteries.
The severity of BPH symptoms and quality of life of patients were assessed by means of the IPSS and QoL questionnaires. Uroflowmetry was used to determine the degree of impairments of urination. Besides, to specify the dimensions of the prostate, its volume and to measure the amount of residual urine investigators performed transabdominal ultrasound examination (if necessary also transcatheter ultrasound), as well as digital rectal examination and blood analysis for PSA and, if indicated, biopsy of the prostate to rule out cancerous prostatic lesion.
The key method in the study was 24-hour ECG (Holter) monitoring using the Schiller MT 200 device (Switzerland). Deciphering the data of 24-hour ECG monitoring, investigators examined the dynamics of the ST segment and changes in the cardiac rhythm during urination, which was registered by the patient by depressing the respective button on the device and keeping a diary, and totally during the whole period (24 hours) of Holter monitoring.
Then, some patients (n=48) received therapy with tamsulosin for 30 days at a dose of 0.4 mg at night, and others (n=35) underwent TUR for prostatic hyperplasia. After a month on the background of continuing cardiac therapy and administration of tamsulosin in the group of conservative treatment investigators evaluated the subjective symptomatology by the IPSS and QoL scales, performed uroflowmetry, ultrasound examination of the prostate and the volume of residual urine, standard ECG and repeat 24-hour ECG monitoring with registering the time of urination. If necessary, the patients filled in the Seattle Angina Questionnaire again.
All procedures performed in the study were in accordance with standard clinical care and were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Study was approved by Sechenov University IRB. Informed consent was obtained from all individual participants included in the study.
The data were processed using the methods of descriptive statistics, Student's t-test for paired values, in the programme BIOSTAT.
- Conditions
- Ischaemic Heart Disease (IHD), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS)
- Being tested
- Tamsulosin Oral Capsule, TURP
- Medical subject headings
- Coronary Artery Disease, Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Oral CapsuleDrug
Also called Tamsulosin
Tamsulosin Oral Capsule - alpha-1-adrenoblocker for treatment LUTS/BPH 0.4 mg
TURPProcedure or surgery
Routine transurethral prostatic resection
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | It included the patients in whom during urination certain changes in HM were registered. The Group 1 patients' age varied from 63 to 79 years (mean 68.6±4.94 years). Nearly all except two patients (cardiac background of these patients did not require medical or surgical correction) from this group received cardiotropic therapy which did not change during one-month follow-up. |
| Tamsulosin | Active comparator | This group enrolled 28 patients in whom primary HM detected certain alterations (VE, SVE, ST segment depression) which did not coincide with the act of urination. The age of patients was from 57 to 81 years (mean 71.3±1.1 years). In order to improve impaired urination were also received Tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow up and treatment. Tamsulosin Oral Capsule. Receives: Drug: Tamsulosin Oral Capsule |
| TURP | Active comparator | This group was composed of patients for whom after examination for symptoms of IHD and LUTS/BPH a decision was made on the necessity to perform operative treatment of BPH. TURP operation was indicated due to pronounced urination disorders which were most important amongst the patient's complaints. The patients' age varied from 59 to 77 years (mean 67.5±2.1 years). Receives: Procedure: TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from the baseline 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions.
Changes of the ST segment and of the cardiac rhythm during urination, which was registered by the patient by depressing the respective button on the device and keeping a diary, and totally during the whole period (24 hours) of Holter monitoring.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Sep 2015
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischaemic Heart Disease (IHD)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinarov Andrey, I.M. Sechenov First Moscow State Medical University
- Investigators
- Andrey Z Vinarov, PhD, Principal investigator, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856242
- Sponsor's protocol ID
- 03-19
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fiev DN, Vinarov AZ, Tsarichenko DG, Kopylov PY, Demidko YL, Syrkin AL, Rapoport LM, Alyaev YG, Glybochko PV. Holter Monitoring (24-Hour ECG) Parameter Dynamics in Patients with Ischemic Heart Disease and Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Adv Ther. 2019 Aug;36(8):2072-2085. doi: 10.1007/s12325-019-00977-8. Epub 2019 May 30.
PubMed 31148056
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Prostatic Hyperplasia and Ischemic Heart DIsease
- ClinicalTrials.gov ID
- NCT03856242
- Acronym / sponsor ID
- 03-19
- Conditions
- Ischaemic Heart Disease (IHD), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 27 Feb 2019 (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.
To examine the dynamics of 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions resulted from benign prostatic hyperplasia (BPH) with the indications for either conservative or operative treatment.
A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.
Detailed description
A total of eighty-three 57-to-81-year-old (mean age 70.4±5.75 years) patients diagnosed with BPH and accompanying IHD were examined at the Institute of Urology and Human Reproductive Health and Clinic of Cardiology of the Sechenov University.
Depending on the results of primary Holter monitoring (HM) and the method of correction (medicamentous or operative) of LUTS/BPH, all patients were subdivided into 3 groups:
Group 1 (n=20) included patients in whom primary HM revealed ECG alterations appearing or deteriorating during urination; all these patients along with recommended cardiotropic therapy, for improving impaired urination received tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow-up and treatment.
Group 2 (n=28) was composed of patients who had Holter-detected diagnostically significant ECG alterations, however, nonrelated to the act of urination; all these patients, along with the recommended cardiac therapy, in order to improve impaired urination were also received tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow up and treatment.
Group 3 (n=35) consisted of patients with BPH and IHD found to have pronounced impairments severe obstructed urination and transurethral resection of the prostate (TURP) was performed. Like in the previous group HM demonstrated diagnostically significant changes in the ECG, not however related to the act of urination.
Criteria for inclusion into the study: 1) patient's consent; 2) absence of severe accompanying pathology hampering carrying out the study (mental disorders, musculoskeletal system diseases, oncological diseases); 3) LUTS/BPH, with the total score by the IPSS more than or equal to 8; 4) functional class II-IV angina of effort; 5) non-ST segment depression postinfarction cardiosclerosis.
Exclusion criteria: 1) presence of cystostomic drainage; 2) long-term medicamentous therapy of prostatic hyperplasia (alpha-adrenoblockers, 5-alpha-reductase inhibitors and others) - for the groups of patients of conservative treatment of BPH; 3) patients after operative treatment of prostatic hyperplasia (TUR of prostatic hyperplasia, transvesical adenomectomy, etc.); 4) urinary bladder stones; 5) acute urinary retention; 6) "paradoxical" ischuria; 7) changes on the ECG hampering its interpretation (complete left bundle branch block, cicatricial changes after endured myocardial infarction, permanent form of ciliary arrhythmia); 8) acute forms of ischaemic heart disease.
Criteria for withdrawal: voluntary refusal of the patient from further follow up;
Beside interviewing (in the presence of angina, the patients filled in the Seattle Angina Questionnaire), the patients were subjected to measuring arterial pressure on both arms, biochemical blood analysis (measuring the level of triglycerides, cholesterol, if necessary, high-, low- and very-low density lipoproteins), standard 12-lead ECG. All patients in order to verify the diagnosis of IHD underwent detailed examination in the settings of a cardiological hospital including, if required, the following studies: tread-mill, stress-echocardiography, coronarography, multispiral computed tomography of the coronary arteries.
The severity of BPH symptoms and quality of life of patients were assessed by means of the IPSS and QoL questionnaires. Uroflowmetry was used to determine the degree of impairments of urination. Besides, to specify the dimensions of the prostate, its volume and to measure the amount of residual urine investigators performed transabdominal ultrasound examination (if necessary also transcatheter ultrasound), as well as digital rectal examination and blood analysis for PSA and, if indicated, biopsy of the prostate to rule out cancerous prostatic lesion.
The key method in the study was 24-hour ECG (Holter) monitoring using the Schiller MT 200 device (Switzerland). Deciphering the data of 24-hour ECG monitoring, investigators examined the dynamics of the ST segment and changes in the cardiac rhythm during urination, which was registered by the patient by depressing the respective button on the device and keeping a diary, and totally during the whole period (24 hours) of Holter monitoring.
Then, some patients (n=48) received therapy with tamsulosin for 30 days at a dose of 0.4 mg at night, and others (n=35) underwent TUR for prostatic hyperplasia. After a month on the background of continuing cardiac therapy and administration of tamsulosin in the group of conservative treatment investigators evaluated the subjective symptomatology by the IPSS and QoL scales, performed uroflowmetry, ultrasound examination of the prostate and the volume of residual urine, standard ECG and repeat 24-hour ECG monitoring with registering the time of urination. If necessary, the patients filled in the Seattle Angina Questionnaire again.
All procedures performed in the study were in accordance with standard clinical care and were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Study was approved by Sechenov University IRB. Informed consent was obtained from all individual participants included in the study.
The data were processed using the methods of descriptive statistics, Student's t-test for paired values, in the programme BIOSTAT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –It included the patients in whom during urination certain changes in HM were registered. The Group 1 patients' age varied from 63 to 79 years (mean 68.6±4.94 years). Nearly all except two patients (cardiac background of these patients did not require medical or surgical correction) from this group received cardiotropic therapy which did not change during one-month follow-up. |
| Tamsulosin | Active comparator | Drug: Tamsulosin Oral CapsuleThis group enrolled 28 patients in whom primary HM detected certain alterations (VE, SVE, ST segment depression) which did not coincide with the act of urination. The age of patients was from 57 to 81 years (mean 71.3±1.1 years). In order to improve impaired urination were also received Tamsulosin at a dose of 0.4 mg once daily (in the morning) for the whole period of follow up and treatment. Tamsulosin Oral Capsule. |
| TURP | Active comparator | Procedure: TURPThis group was composed of patients for whom after examination for symptoms of IHD and LUTS/BPH a decision was made on the necessity to perform operative treatment of BPH. TURP operation was indicated due to pronounced urination disorders which were most important amongst the patient's complaints. The patients' age varied from 59 to 77 years (mean 67.5±2.1 years). |
Who may qualify
- Ages
- 57 to 81 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LUTS/BPH, with the total score by the IPSS more than or equal to 8;
- Functional class II-IV angina of effort;
- Non-ST segment depression postinfarction cardiosclerosis.
Key exclusion criteria (7 listed)
- Presence of cystostomic drainage;
- Long-term LUTS/BPH therapy of prostatic hyperplasia (alpha-adrenoblockers, 5-alpha-reductase inhibitors and others) - for the groups of patients of conservative treatment of BPH;
- Patients after operative treatment of prostatic hyperplasia (TUR of prostatic hyperplasia, transvesical adenomectomy, etc.);
- Urinary bladder stones;
- Acute urinary retention;
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 |
|---|---|---|
| Tamsulosin Oral CapsuleAlso: TamsulosinTamsulosin Oral Capsule - alpha-1-adrenoblocker for treatment LUTS/BPH 0.4 mg | Drug | Tamsulosin |
| TURPRoutine transurethral prostatic resection | Procedure or surgery | TURP |
Primary outcome
Changes from the baseline 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions.
Time frame: up to 6 months
Changes of the ST segment and of the cardiac rhythm during urination, which was registered by the patient by depressing the respective button on the device and keeping a diary, and totally during the whole period (24 hours) of Holter monitoring.
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 27 Feb 2019.
- Derived from this study: PubMed 31148056Fiev DN, Vinarov AZ, Tsarichenko DG, Kopylov PY, Demidko YL, Syrkin AL, Rapoport LM, Alyaev YG, Glybochko PV. Holter Monitoring (24-Hour ECG) Parameter Dynamics in Patients with Ischemic Heart Disease and Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Adv Ther. 2019 Aug;36(8):2072-2085. doi: 10.1007/s12325-019-00977-8. Epub 2019 May 30.
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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.
Andrey Z Vinarov, PhD principal investigator
I.M. Sechenov First Moscow State Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin Oral Capsule and TURP in people with Ischaemic Heart Disease (IHD) and Benign Prostatic Hyperplasia (BPH), run by I.M. Sechenov First Moscow State Medical University.
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 3 inclusion and 7 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes from the baseline 24 - hours ECG monitoring parameters (Holter monitoring) in patients with ischaemic heart disease (IHD) before and after treatment of voiding dysfunctions. (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856242, which also lists 1 linked publication.
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 27 Feb 2019.