A Trial of Telmisartan Prevention of Cardiovascular Disease

NCT01075698 | Completed Phase 4 DMC

• 1 other identifier: H21-1
• Study Type: interventional
• Target: 1,228
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Type 2 Diabetes; Cerebrovascular disease; Coronary Artery Disease; Chronic Kidney Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• The effects of ARB therapy and that of standard therapy except ARB on the biomarker levels (UACR and BNP)

  for three years

Secondary Outcomes (1)

• 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)

  for three years

Study Arms (2)

Non-ARB group

ACTIVE COMPARATOR

Drug: Non-ARB (standard therapy)

ARB group

ACTIVE COMPARATOR

Drug: ARB (Telmisartan)

Interventions

Non-ARB (standard therapy) DRUG

Blood pressure lowering therapy except ARB

Non-ARB group

ARB (Telmisartan) DRUG

Telmisartan 20-80 mg/day

ARB group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients
• Age: ≥ 40 to \< 80
• 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.
• Patients who have given consent to participate in the present study.
• Cardiovascular risks:
• Diabetes mellitus; Type 2 diabetes mellitus
• 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)
• 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
• Brain; Previous cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient cerebral ischemic attack noted more than 6 months before obtaining the informed consent
• 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

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study.
• Type 1 diabetes mellitus
• Severe renal disorders (serum creatinine of ≥ 2.0 mg/dL)
• 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
• Diagnosis of heart failure (NYHA III or IV class )
• Virulent hypertension and secondary hypertension
• Pregnant women
• Clinically relevant allergic symptoms or past history of hypersensitivity to drugs / significant adverse drug reactions
• Extremely poor bile secretion or serious liver disorders
• Treatment-required malignant tumors
• Patients who are judged by the physician in charge to be ineligible for the study for any other reasons

Sponsors & Collaborators

• Kumamoto University: lead
• Japan Foundation for Aging and Health: collaborator

Study Sites (1)

Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital

Kumamoto, 860-8555, Japan

Location

Related Publications (2)

• Ogawa H, Soejima H, Matsui K, Kim-Mitsuyama S, Yasuda O, Node K, Yamamuro M, Yamamoto E, Kataoka K, Jinnouchi H, Sekigami T; ATTEMPT-CVD investigators. A trial of telmisartan prevention of cardiovascular diseases (ATTEMPT-CVD): Biomarker study. Eur J Prev Cardiol. 2016 Jun;23(9):913-21. doi: 10.1177/2047487315603221. Epub 2015 Aug 31.

  PMID: 26324672 BACKGROUND

• Kim-Mitsuyama S, Soejima H, Yasuda O, Node K, Jinnouchi H, Yamamoto E, Sekigami T, Ogawa H, Matsui K. Reduction in hsCRP levels is associated with decreased incidence of cardiovascular events in Japanese hypertensive women but not in men. Sci Rep. 2020 Oct 12;10(1):17040. doi: 10.1038/s41598-020-73905-4.

  PMID: 33046765 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Cerebrovascular Disorders; Coronary Artery Disease; Renal Insufficiency, Chronic; Peripheral Arterial Disease

Interventions

Standard of Care; Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hisao Ogawa, Prof., MD, PhD

  Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: July 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

JP (1)