Clinical trial NCT02298556: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Diabetes Mellitus
ACE Inhibitors
Calcium Channel Blockers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: MonitorCRO
First posted: 2014-11-24
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: State Hospital

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Absolute change in systolic blood pressure
timeFrame: from baseline to week 8
Secondary outcomes:
measure: Absolute change in diastolic blood pressure (DBP)
timeFrame: from baseline to week 8
measure: Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg
timeFrame: from baseline to week 8
measure: Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)
timeFrame: from baseline to week 8
measure: Absolute change of heart rate
timeFrame: from baseline to week 8
measure: Correlation between absolute change in blood pressure and absolute change in heart rate
timeFrame: from baseline to week 8
measure: The absolute change in PR interval on electrocardiography
timeFrame: from baseline to week 8
measure: The absolute change in HbA1c (if available)
timeFrame: from baseline to week 8
measure: The absolute change in microalbuminuria (if available)
timeFrame: from baseline to week 8
measure: The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event
timeFrame: from baseline to week 8
measure: The correlation between physician's office and home blood pressure measurements (Difference in medians)
timeFrame: from baseline to week 8
measure: Blood pressure variability (daily or hourly) in home blood pressure measurement
timeFrame: from baseline to week 8
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Research facility ID ORG-001108
city: Ankara
country: Turkey
facility: Research facility ID ORG-001030
city: Ankara
country: Turkey
facility: Yıldırım Beyazıt University Yenimahalle Training and Research Hospital
city: Antalya
country: Turkey
facility: Research facility ID ORG-001111
city: Aydın
country: Turkey
facility: Research facility ID ORG-001120
city: Aydın
country: Turkey
facility: Research facility ID ORG-001119
city: Balıkesir
country: Turkey
facility: Research facility ID ORG-001116
city: Burdur
country: Turkey
facility: Research facility ID ORG-001112
city: Erzurum
country: Turkey
facility: Erzurum Regional Training and Research Hospital
city: Erzurum
country: Turkey
facility: Atatürk University Aziziye Research Hospital
city: İstanbul
country: Turkey
facility: Research facility ID ORG-001118
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital
city: İstanbul
country: Turkey
facility: Research facility ID ORG-001117
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Training and Research Hospital
city: İstanbul
country: Turkey
facility: Research facility ID ORG-001125
city: Karabük
country: Turkey
facility: Research facility ID ORG-001113
city: Konya
country: Turkey
facility: Research facility ID ORG-001110
city: Kırıkkale
country: Turkey
facility: Research facility ID ORG-001115
city: Trabzon
country: Turkey
facility: Research facility ID ORG-001122
city: Uskudar
country: Turkey
facility: Uskudar PublicHospital
city: Yalova
country: Turkey
facility: Yalova Public Hospital
city: Zonguldak
country: Turkey
facility: Research facility ID ORG-001124
city: Çorum
country: Turkey
facility: Research facility ID ORG-001123
Study officials:
affiliation: Hacettepe University Faculty of Medicine Hospital Cardiology Clinic
name: Enver Atalar, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.