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Completed

NCT Number: 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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research facility ID ORG-001108, Adana, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Absolute change in systolic blood pressure

    Time frame: from baseline to week 8

    mmHg

Secondary outcomes

  1. Absolute change in diastolic blood pressure (DBP)

    Time frame: from baseline to week 8

    mmHg

  2. Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg

    Time frame: from baseline to week 8

  3. Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg)

    Time frame: from baseline to week 8

  4. Absolute change of heart rate

    Time frame: from baseline to week 8

    beat/min

  5. Correlation between absolute change in blood pressure and absolute change in heart rate

    Time frame: from baseline to week 8

  6. The absolute change in PR interval on electrocardiography

    Time frame: from baseline to week 8

    ms. The PR interval indicates "atrioventricular conduction time".

  7. The absolute change in HbA1c (if available)

    Time frame: from baseline to week 8

  8. The absolute change in microalbuminuria (if available)

    Time frame: from baseline to week 8

    mg/mmol

  9. 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

  10. The correlation between physician's office and home blood pressure measurements (Difference in medians)

    Time frame: from baseline to week 8

    mmHg

  11. Blood pressure variability (daily or hourly) in home blood pressure measurement

    Time frame: from baseline to week 8

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • MonitorCRO

Registry information

Official study 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

Acronym: HARVEST-TR

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 24, 2014
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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