HypertensionHARVEST-TRNCT02298556
An Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Calcium Channel Blocker Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes
An observational study of Hypertension, run by Abbott at 23 sites in Turkey (Türkiye).
Trial summary
To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 270 participants
- Where
- 23 sitesTurkey (Türkiye)
- Study dates
- Oct 2014to 8 Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: State Hospital
Who may be able to join
- Male or female
- ≥ 18 years old
- Has been already diagnosed with hypertension
- Has been already diagnosed with type 2 diabetes mellitus
- Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment
- Heart rate ≥70 beat per minute
Who cannot join
- Pregnant or breast feeding female
- Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
- Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker;
- Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
- Is currently participating in another clinical or non-clinical study
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Turkey (Türkiye)23 sites
Research facility ID ORG-001108
Adana, 01330
Research facility ID ORG-001030
Ankara, 06230
Yıldırım Beyazıt University Yenimahalle Training and Research Hospital
Ankara, 6170
Research facility ID ORG-001111
Antalya, 07059
Research facility ID ORG-001120
Aydin, 09020
Research facility ID ORG-001119
Aydin, 09100
Research facility ID ORG-001116
Balıkesir, 10000
Research facility ID ORG-001112
Burdur, 15300
Research facility ID ORG-001123
Çorum, 19200
Erzurum Regional Training and Research Hospital
Erzurum, 25040
Atatürk University Aziziye Research Hospital
Erzurum, 25080
Research facility ID ORG-001118
Istanbul, 34098
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
Research facility ID ORG-001117
Istanbul, 34303
Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Training and Research Hospital
Istanbul, 34668
Research facility ID ORG-001125
Istanbul, 34920
Research facility ID ORG-001113
Karabük, 78100
Research facility ID ORG-001115
Kirikkale, 71400
Research facility ID ORG-001110
Konya, 42250
Research facility ID ORG-001122
Trabzon, 61800
Uskudar PublicHospital
Üsküdar, 34662
Yalova Public Hospital
Yalova, 77000
Research facility ID ORG-001124
Zonguldak, 67900
About this study
Official title: A Prospective Noninterventional, Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Non-dihydropyridine Calcium Channel Blocker Single Pill Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes Mellitus
To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes
- Conditions
- Hypertension
- Keywords
- Hypertension, Diabetes Mellitus, ACE Inhibitors, Calcium Channel Blockers
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Hypertensive patients with elevated heart rate and type 2 diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in systolic blood pressure
mmHg
Measured: from baseline to week 8
Secondary outcomes (11)
Absolute change in diastolic blood pressure (DBP)
mmHg
Measured: from baseline to week 8
Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg
Measured: from baseline to week 8
Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)
Measured: from baseline to week 8
Absolute change of heart rate
beat/min
Measured: from baseline to week 8
Correlation between absolute change in blood pressure and absolute change in heart rate
Measured: from baseline to week 8
The absolute change in PR interval on electrocardiography
ms. The PR interval indicates "atrioventricular conduction time".
Measured: from baseline to week 8
The absolute change in HbA1c (if available)
Measured: from baseline to week 8
The absolute change in microalbuminuria (if available)
mg/mmol
Measured: from baseline to week 8
The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event
Measured: from baseline to week 8
The correlation between physician's office and home blood pressure measurements (Difference in medians)
mmHg
Measured: from baseline to week 8
Blood pressure variability (daily or hourly) in home blood pressure measurement
Measured: from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2014
- Primary completion31 Dec 2015
- Study completion8 Mar 2016
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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Responsible party
- Sponsor
- Investigators
- Enver Atalar, Prof. Dr., Principal investigator, Hacettepe University Faculty of Medicine Hospital Cardiology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298556
- Sponsor's protocol ID
- GSS-13-0019
- Acronym
- HARVEST-TR
- Status last verified
- Mar 2018
- First submitted
- 20 Nov 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Atalar E, Eskin F, Tugtekin HB, Karabulut A, Kanyilmaz S, Kirbiyik H, Ozyildiz AG. A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study. Biomed Res Int. 2020 Sep 5;2020:2123601. doi: 10.1155/2020/2123601. eCollection 2020.
PubMed 32964020
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Noninterventional, Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Non-dihydropyridine Calcium Channel Blocker Single Pill Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02298556
- Acronym / sponsor ID
- HARVEST-TR / GSS-13-0019
- Conditions
- Hypertension
- Keywords
- Hypertension, Diabetes Mellitus, ACE Inhibitors, Calcium Channel Blockers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- MonitorCRO
- Study start
- Oct 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 8 Mar 2016 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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 describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | –Hypertensive patients with elevated heart rate and type 2 diabetes mellitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- State Hospital
Key inclusion criteria (6 listed)
- Male or female
- ≥ 18 years old
- Has been already diagnosed with hypertension
- Has been already diagnosed with type 2 diabetes mellitus
- Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment
Key exclusion criteria (5 listed)
- Pregnant or breast feeding female
- Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
- Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker;
- Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
- Is currently participating in another clinical or non-clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute change in systolic blood pressure
Time frame: from baseline to week 8
mmHg
11 secondary outcomes
Absolute change in diastolic blood pressure (DBP)
Time frame: from baseline to week 8
Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg
Time frame: from baseline to week 8
Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)
Time frame: from baseline to week 8
Absolute change of heart rate
Time frame: from baseline to week 8
Correlation between absolute change in blood pressure and absolute change in heart rate
Time frame: from baseline to week 8
The absolute change in PR interval on electrocardiography
Time frame: from baseline to week 8
The absolute change in HbA1c (if available)
Time frame: from baseline to week 8
The absolute change in microalbuminuria (if available)
Time frame: from baseline to week 8
The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event
Time frame: from baseline to week 8
The correlation between physician's office and home blood pressure measurements (Difference in medians)
Time frame: from baseline to week 8
Blood pressure variability (daily or hourly) in home blood pressure measurement
Time frame: from baseline to week 8
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 Mar 2018.
- Derived from this study: PubMed 32964020Atalar E, Eskin F, Tugtekin HB, Karabulut A, Kanyilmaz S, Kirbiyik H, Ozyildiz AG. A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study. Biomed Res Int. 2020 Sep 5;2020:2123601. doi: 10.1155/2020/2123601. eCollection 2020.
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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.
Enver Atalar, Prof. Dr. principal investigator
Hacettepe University Faculty of Medicine Hospital Cardiology Clinic
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Abbott at 23 sites in Turkey (Türkiye).
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 6 inclusion and 5 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Turkey (Türkiye). 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?
Absolute change in systolic blood pressure (time frame: from baseline to week 8). 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 NCT02298556, 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 Mar 2018.