Nijmegen Antihypertensive Management Improvement Study

NCT00457483 | Completed Phase 4

• 1 other identifier: NAMIS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

High blood pressure is an important risk factor for diseases of heart and blood vessels like myocardial infarction and stroke. Many patients are not treated to target blood pressures, even though good blood pressure lowering drugs are available. Not all blood pressure drugs are equally effective in individual patients. We hypothesize that individual patient characteristics can predict the best response on different blood pressure lowering drugs. In this study we will investigate whether a set of patient characteristics (anthropometric and laboratory) obtained before treatment may predict the blood pressure lowering response to representatives of two groups of drugs: those that inhibit renin-angiotensin system activity and those that decrease blood volume.

Conditions

Primary Hypertension

Keywords

hypertension; diuretic; angiotensin receptor blockers; prediction

Outcome Measures

Primary Outcomes (2)

• Blood pressure response as determined by Ambulatory Blood Pressure Monitoring

  4 week treatment period

• Patient characteristics that predict this blood pressure response

  4 week treatment period

Interventions

hydrochlorothiazide DRUG

12.5 mg once-a-day

valsartan, 80 mg once-a-day DRUG

80 mg once-a-day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years with newly diagnosed hypertension in general practice
• hypertension is defined as either \> 140 mm Hg systolic or \> 90 mm Hg diastolic on three separate days.

You may not qualify if:

• History of cardiovascular disease (transient ischemic attack (TIA), stroke, myocardial infarction (MI), peripheral arterial disease (PAD), atrial fibrillation (AF), angina pectoris (AP), Diabetes Mellitus)
• Unable to understand and/or speak Dutch
• Severe hypertension (\> 200/120 mmHg)
• Irregular pulse
• Use of antihypertensive medication
• Contraindication to one of the trial drugs
• Serious suspicion on secondary hypertension

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Nijmegen monitoring project coordinated from Nijmegen

Nijmegen, Netherlands

Location

Related Publications (2)

• van der Wel MC, Biermans M, Akkermans R, Lenders JWM, van Weel C, Deinum J. Patient characteristics do not predict the individual response to antihypertensive medication: a cross-over trial. Fam Pract. 2018 Jan 16;35(1):67-73. doi: 10.1093/fampra/cmx075.

  PMID: 28968870 DERIVED

• van der Wel MC, Buunk IE, van Weel C, Thien TA, Bakx JC. A novel approach to office blood pressure measurement: 30-minute office blood pressure vs daytime ambulatory blood pressure. Ann Fam Med. 2011 Mar-Apr;9(2):128-35. doi: 10.1370/afm.1211.

  PMID: 21403139 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Hydrochlorothiazide; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Jaap Deinum, MD PhD

  University Medical Center St Radboud Nijmegen

  PRINCIPAL INVESTIGATOR

• Carel Bakx, MD PhD

  University Medical Center St Radboud Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2011-04

Locations

NL (1)