A Trial of Telmisartan Prevention of Cardiovascular Disease

NCT ID: NCT01075698

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2016-03-31

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.

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)

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-ARB group

Group Type: ACTIVE_COMPARATOR

Non-ARB (standard therapy)

Intervention Type: DRUG

Blood pressure lowering therapy except ARB

ARB group

Group Type: ACTIVE_COMPARATOR

ARB (Telmisartan)

Intervention Type: DRUG

Telmisartan 20-80 mg/day

Interventions

Non-ARB (standard therapy)

Blood pressure lowering therapy except ARB

Intervention Type: DRUG

ARB (Telmisartan)

Telmisartan 20-80 mg/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Foundation for Aging and Health

OTHER

Sponsor Role: collaborator

Kumamoto University

OTHER

Sponsor Role: lead

Responsible Party

Hirofumi Soejima

Associate Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hisao Ogawa, Prof., MD, PhD

Role: STUDY_CHAIR

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

Shokei Kim-Mitsuyama, Prof., MD, PhD

Role: STUDY_DIRECTOR

Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University

Koichi Node, Prof, MD, PhD

Role: STUDY_DIRECTOR

Department of Cardiovascular and Renal Medicine, Saga University Faculty of Medicine

Hirofumi Soejima, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Health Care Center / Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Osamu Yasuda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital

Locations

Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital

Kumamoto, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 26324672 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33046765 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

H21-1

Identifier Type: -

Identifier Source: org_study_id