TELSYS - TELmisartan Effectiveness in Isolated SYStolic Hypertension Versus Systolic/Diastolic Hypertension Patients Aged 55 or Older (TELSYS)

Observational Study in Everyday Medical Practice of the Effectiveness of Telmisartan for Treatment of Isolated Systolic Hypertension in Comparison With Systolic/Diastolic Hypertension in Patients Aged 55 or Older

The aim of this study is to compare the effect of treatment with telmisartan on patients in whom the systolic BP is approximately 12 weeks after starting treatment under control for the first time between patients with isolated systolic hypertension (ISH) at the beginning to patients with systolic/diastolic hypertension (SDH)

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan; Drug: Telmisartan combined with hydrochlorothiazide

• Study Type: Observational
• Enrollment (Actual): 3320

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 55 years or older with either isolated systolic- or with systolic and diastolic hyptertension

Description

Inclusion Criteria:

• Age ≥ 55, with no upper limit
• Patient who has been treated and followed up for more than 12 months by the same general practitioner (GP)

• Hypertension measured at least once during the past 12 months and not under control at the time of inclusion in the study:

  • isolated systolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure < 90 mmHg or
  • systolic/diastolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg; or
  • systolic blood pressure ≥ 130 and diastolic blood pressure ≥ 80 mmHg, if the patient has diabetes or chronic renal insufficiency
• Treatment with one or more antihypertensives which remains unchanged during the month prior to collecting the data
• Decision by the GP to add telmisartan (either in combination with hydrochlorothiazide (HCTZ) or not) to the antihypertensive treatment; this decision is made by the treating doctor regardless of participation in the study. The prescription is issued in the normal way, in accordance with the conditions set down in the marketing authorisation
• Written informed consent of the patient to collect his/her data

Exclusion Criteria:

• The patient refuses to allow his/her data to be collected
• Change in the antihypertensive treatment during the month prior to collection of the data
• Blood pressure under control
• The recommended target values corresponding to control of diastolic and systolic blood pressure are important because of the diseases associated with hypertension consequently, and in order to prevent the collection process becoming too complicated, data from patients with severe renal insufficiency or with proteinuria of ≥ 1 g/L or more are not collected in the context of this study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Isolated systolic hypertension	Drug: Telmisartan; Drug: Telmisartan combined with hydrochlorothiazide
Systolic and diastolic hypertension	Drug: Telmisartan; Drug: Telmisartan combined with hydrochlorothiazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Normalization of arterial systolic hypertension	Up to 12 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of systolic blood pressure (SBP) response	Up to 12 weeks after start of treatment
Mean decrease in systolic blood pressure	Up to 12 weeks after start of treatment
Number of patients with adverse events	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (ACTUAL): October 1, 2006

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (ESTIMATE): September 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Heart Murmurs; Hypertension; Systolic Murmurs; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Telmisartan
• Other Study ID Numbers: 502.510