Clinical trial NCT02242877: TELSYS - TELmisartan Effectiveness in Isolated SYStolic Hypertension Versus Systolic/Diastolic Hypertension Patients Aged 55 or Older
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 3320
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 55 years or older with either isolated systolic- or with systolic and diastolic hyptertension

Brief summary: 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)


Eligibility criteria: 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

Primary outcomes:
measure: Normalization of arterial systolic hypertension
timeFrame: Up to 12 weeks after start of treatment
Secondary outcomes:
measure: Assessment of systolic blood pressure (SBP) response
timeFrame: Up to 12 weeks after start of treatment
measure: Mean decrease in systolic blood pressure
timeFrame: Up to 12 weeks after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
Study officials:
References: