Antihypertensive treatment in prehypertensive patients

A comparative study on reduction in major cardiovascular events (pharmacological treatment versus diet control) in pre-hypertensive patient between pharmacotherapy and diet control: a randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191002044961N1

Enrollment

1620

Registered

2019-12-03

Start date

2019-12-15

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prehypertension.

Interventions

Intervention 1: The intervention group will be administered an antihypertensive regimen (amlodipine/valsartan at an initial dose of 5/80 mg

Valzomix®, Abidi pharmaceutical Company, Tehran, Iran) taken daily for 36 months, along with a low-salt, low-fat diet aimed at maintaining SBP below 130/80 mmHg. In cases of uncontrolled BP (above 130

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients with Systolic blood presure (SBP)between 130-140 mmhg and DBP below 90 mmHg Atherosclerosis cardiovascular disease (ASCVD) risk equal or more than 7.5 percent Minimum age of 18 years old

Exclusion criteria

Exclusion criteria: Presence of Diabetes mellitus(DM) before starting survey Presence of Cerebrovascular accident (CVA) before starting survey Presence of heart failure(HF) before starting survey Presence of myocardial infarction (MI) before starting survey Patients recieved antihypertensive, statin, and other medications due to other reasons

Design outcomes

Primary

Measure	Time frame
The incidence of cardiovascular death, Myocardial Infarction (MI), stroke, or Heart Failure (HF). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of this composite endpoint during this reaserch.	—

Secondary

Measure	Time frame
The incidence of mortality rate due to cardiovascular events (cardiovascular death). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of cardiovascular death during this reaserch.;The incidence of Myocardial Infarction (MI). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of myocardial infarction (MI) during this reaserch.;The incidence of cerebrovascular accident (CVA-stroke). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of stroke (CVA) during this reaserch.;The incidence of Heart Failure (HF). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of heart failure (HF) during this reaserch.;The incidence of cardiovascular death, MI, or stroke. Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of this composite endpoint during this reaserch.;The incidence of adverse events. Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of adverse events during this reaserch.	—

Measure

Time frame

The incidence of mortality rate due to cardiovascular events (cardiovascular death). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of cardiovascular death during this reaserch.;The incidence of Myocardial Infarction (MI). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of myocardial infarction (MI) during this reaserch.;The incidence of cerebrovascular accident (CVA-stroke). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of stroke (CVA) during this reaserch.;The incidence of Heart Failure (HF). Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of heart failure (HF) during this reaserch.;The incidence of cardiovascular death, MI, or stroke. Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of this composite endpoint during this reaserch.;The incidence of adverse events. Timepoint: Every 6 months from the beginning of the study until the end of the trial. Method of measurement: We will evaluate the incidence of adverse events during this reaserch.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Armin Attar

Shiraz University of Medical Sciences

attarar@sums.ac.ir+98 917 714 1797

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026