Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT01075698
First received: February 24, 2010
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  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.


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:

Drug Information available for: Telmisartan
U.S. FDA Resources

Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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 without ARB
Active Comparator: ARB group Drug: ARB (Telmisartan)
Telmisartan 20-80 mg/day

Detailed Description:

Hypertension is an important risk factor for cardiovascular diseases. Nowadays, angiotensin II receptor blockers (ARBs) are widely used for the treatment of hypertension. These ARBs are known to possess organ-protecting effects beyond blood pressure lowering effect. The ONTARGET study recently conducted in over 25,000 patients with vascular diseases or high risk diabetes proved that the ARB was equivalent to the angiotensin converting enzyme inhibitor in terms of the primary endpoint of cardiovascular diseases. In the substudy of HOPE in which the association of various biomarkers with primary endpoint was assessed, on the other hand, a significant association was demonstrated with the hazard ratios of the primary endpoint to plasma pro-brain natriuretic peptide (Nt-proBNP) and microalbuminuria. 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.

  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
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
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: Hisao Ogawa, Prof., 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: June 22, 2011
Health Authority: Japan: Institutional Review Board

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
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013