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Trial record 1 of 1 for:    NCT03209154
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An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment (IDA)

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ClinicalTrials.gov Identifier: NCT03209154
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
University of Oslo
Haukeland University Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
Sverre Erik Kjeldsen, Oslo University Hospital

Brief Summary:
The aim of the study is to investigate and explore the most important aspects of drug-adherence in the treatment of hypertension in order to improve treatment and blood pressure control, implying that new knowledge will reduce morbidity and mortality.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Diagnostic Test: Therapeutic drug monitoring Device: Home blood pressure monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
Study Group intervention: Therapeutic drug monitoring.
Diagnostic Test: Therapeutic drug monitoring
Therapeutic drug monitoring will be performed.

Active Comparator: Control Group
Control Group intervention: No intervention first 3 months. After 3 months of follow-up, half of the patients in the Control Group will be randomized to perform home blood pressure monitoring as an intervention. No intervention in the other half.
Device: Home blood pressure monitoring
Patients will perform home blood pressure monitoring at home.




Primary Outcome Measures :
  1. Blood pressure control [ Time Frame: 3 months after baseline ]
    Change in systolic daytime ambulatory blood pressure.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Uncontrolled hypertension
  • A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents
  • No planned changes in antihypertensive drugs

Exclusion Criteria:

  • Withdrawal of consent
  • Patients with inadequate Norwegian language skills
  • Positive pregnancy test
  • Known alcohol or drug abuse
  • estimated glomerular filtration rate <30 mL/min/1.73m2
  • Albumin/creatinin ratio >300 mg/mmol
  • Any reason why, in the opinion of the investigator, the patient should not participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209154


Contacts
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Contact: Camilla L Søraas, MD PhD +4722119100 camillalare@yahoo.no
Contact: Sverre E Kjeldsen, MD PhD +4722119100

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Camilla L Søraas, PhD    +4799566088    uxamlu@ous-hf.no   
Contact: Ulla P Hjørnholm, MSc    +4722199338    ullhjo@gmail.com   
Sub-Investigator: Ola U Bergland, MD         
Sub-Investigator: Lene V Halvorsen, MD         
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Haukeland University Hospital
University Hospital of North Norway
Investigators
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Principal Investigator: Sverre E Kjeldsen, MD PhD Oslo University Hospital

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Responsible Party: Sverre Erik Kjeldsen, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03209154     History of Changes
Other Study ID Numbers: 2017/6534
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sverre Erik Kjeldsen, Oslo University Hospital:
Adherence
Therapeutic Drug Monitoring
Patient perspective
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases