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
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Non-ARB (standard therapy)
Drug: ARB (Telmisartan)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial of Telmisartan Prevention of Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-ARB group Drug: Non-ARB (standard therapy)
Blood pressure lowering therapy except ARB
Active Comparator: ARB group Drug: ARB (Telmisartan)
Telmisartan 20-80 mg/day

Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075698

Locations
Japan
Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital
Kumamoto, Japan, 860-8555
Sponsors and Collaborators
Kumamoto University
Japan Foundation For Aging And Health
Investigators
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
  More Information

No publications provided

Responsible Party: Hirofumi Soejima, Associate Professor, MD, PhD, Kumamoto University
ClinicalTrials.gov Identifier: NCT01075698     History of Changes
Other Study ID Numbers: H21-1
Study First Received: February 24, 2010
Last Updated: December 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:
Type 2 Diabetes
Cerebrovascular disease
Coronary Artery Disease
Chronic Kidney Disease
Peripheral Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014