A Trial of Telmisartan Prevention of Cardiovascular Disease (ATTEMPT-CVD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Japan Foundation For Aging And Health
Information provided by (Responsible Party):
Hirofumi Soejima, Kumamoto University
ClinicalTrials.gov Identifier:
NCT01075698
First received: February 24, 2010
Last updated: December 11, 2013
Last verified: December 2013

February 24, 2010
December 11, 2013
July 2009
June 2014   (final data collection date for primary outcome measure)
The effects of ARB therapy and that of standard therapy except ARB on the biomarker levels (UACR and BNP) [ Time Frame: for three years ] [ Designated as safety issue: No ]
The changes of biomarkers such as plasma brain natriuretic peptide, serum high sensitivity c-reactive protein, urine 8-hydroxy- 2- deoxyguanosine, urine albumin creatinine ratio, serum adiponectin, serum high-molecule adiponectin [ Time Frame: for three years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01075698 on ClinicalTrials.gov Archive Site
The effect of the two treatments on the incidence of events, and the relationship between the incidence of events and the biomarker levels (UACR, BNP, urine 8-hydroxy-2-deoxyguanosine, serum adiponectin, serum high-molecule adiponectin, eGFR) [ Time Frame: for three years ] [ Designated as safety issue: No ]
The incidence of cardiovascular events and the relationship between the cardiovascular events and the biomarkers [ Time Frame: for three years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial of Telmisartan Prevention of Cardiovascular Disease
A Trial of Telmisartan Prevention of Cardiovascular Disease

The present research is conducted as a randomized, parallel-group, controlled, open study (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition, onset of cardiovascular events and levels of markers that are associated with cardiovascular events are observed over time to examine the significance of each marker. The biomarkers will be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from the start of the study.

Events are defined as follows; Cerebrovascular events: Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke), transient ischemic attack Coronary events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia Cardiac events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia, heart failure Aortic/peripheral arterial events: Aortic aneurysm, aortic dissection, arteriosclerotic disease (aorta, carotid artery, renal artery, mesenteric artery, peripheral artery, etc.) Complications of diabetes: Diabetic nephropathy*, diabetic retinopathy*, diabetic neuropathy* Aggravation of renal function: Doubling of serum creatinine level, ESRD (initiation of dialysis, renal transplantation)

*Newly occurred or aggravated

The followings will be measured as biomarkers; urinary albumin creatinine rates (UACR), plasma brain natriuretic peptide (BNP), urinary 8-hydroxy-deoxy-guanosine (8-OHdG), serum adiponectin, serum high-molecular weight adiponectin, high sensitivity c-reactive protein (hsCRP), estimated glomerular filtration rate (eGFR)

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Non-ARB (standard therapy)
    Blood pressure lowering therapy except ARB
  • Drug: ARB (Telmisartan)
    Telmisartan 20-80 mg/day
  • Active Comparator: Non-ARB group
    Intervention: Drug: Non-ARB (standard therapy)
  • Active Comparator: ARB group
    Intervention: Drug: ARB (Telmisartan)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria: Patients who meet all of the criteria listed in [1] to [4] below and who have at least one cardiovascular risk listed in [1] to [5] below will be included in the study.

  1. Outpatients
  2. Age: ≥ 40 to < 80
  3. Hypertension: Systolic blood pressure of ≥ 140 mmHg or diastolic blood pressure of ≥ 90 mmHg in the two latest measurements of casual blood pressure (in the sitting position) regardless of treated or untreated condition, or systolic blood pressure of < 140 mmHg and diastolic blood pressure of < 90 mmHg that require antihypertensive treatment.

    Assessment of hypertension: Blood pressure will be measured at least twice at an interval of 1 to 2 minutes. If the measured values obtained are substantially different, additional measurements will be performed and the average of two stable measurements will be used for assessment.

  4. Patients who have given consent to participate in the present study.

Cardiovascular risks:

  1. Diabetes mellitus; Type 2 diabetes mellitus
  2. Kidney; Serum creatinine: 1.2 mg/dL - < 2.0 mg/dL for males, 1.0 mg/dL - < 2.0 mg/dL for females Proteinuria: qualitative value of ≥ +1 (quantitative value: proteinuria with the value of ≥ 0.3 g/g・Cr in casual urine when adjusted with urine creatinine) CKD stage 3 or higher (GFR < 60 mL/min/1.73 m2)
  3. Heart; Previous myocardial infarction noted more than 6 months before obtaining the informed consent Diagnosis of angina pectoris Diagnosis of heart failure (NYHA I or II class) Diagnosis of left ventricular hypertrophy (left ventricular posterior wall of ≥ 12 mm evidenced by echocardiography performed prior to obtaining the informed consent, or Sv1+Rv5 of ≥ 35 mm noted as ECG finding) Diagnosis of transient or persisting atrial fibrillation
  4. Brain; Previous cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient cerebral ischemic attack noted more than 6 months before obtaining the informed consent
  5. Peripheral arterial diseases; Previous lower-limb bypass surgery or angioplasty performed more than 6 months before obtaining the informed consent Ankle-brachial pressure index of < 0.9 or intermittent claudication

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

  1. Type 1 diabetes mellitus
  2. Severe renal disorders (serum creatinine of ≥ 2.0 mg/dL)
  3. Myocardial infarction, percutaneous transluminal angioplasty and bypass surgery of coronary artery/ lower-limb blood vessel, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage and transient cerebral ischemic attack noted within 6 months before initiation of the observation
  4. Diagnosis of heart failure (NYHA III or IV class )
  5. Virulent hypertension and secondary hypertension
  6. Pregnant women
  7. Clinically relevant allergic symptoms or past history of hypersensitivity to drugs / significant adverse drug reactions
  8. Extremely poor bile secretion or serious liver disorders
  9. Treatment-required malignant tumors
  10. Patients who are judged by the physician in charge to be ineligible for the study for any other reasons
Both
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01075698
H21-1
Yes
Hirofumi Soejima, Kumamoto University
Kumamoto University
Japan Foundation For Aging And Health
Study Chair: Hisao Ogawa, Prof., MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Study Director: Shokei Kim-Mitsuyama, Prof., MD, PhD Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University
Study Director: Koichi Node, Prof, MD, PhD Department of Cardiovascular and Renal Medicine, Saga University Faculty of Medicine
Principal Investigator: Hirofumi Soejima, MD, PhD Health Care Center / Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Principal Investigator: Osamu Yasuda, MD, PhD Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital
Kumamoto University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP