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Not yet taking people in ChinaPhase 4

Folic acid and tighter blood pressure control in brain small vessel disease with hypertension

Tests folic acid and lower blood pressure targets against stroke in hypertension.

Key facts

Who runs it
Beijing Tiantan Hospital
Where
Beijing, ChinaSee the site
Trial code
Registry title
Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD
Status
Not yet recruiting
Phase
Phase 4
People taking part
15,000 people, planned
Started
31 Dec 2021
Expected to end
31 Dec 2028
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Amlodipine folic acid 5.8mg+intensive antihypertensive therapy
  • Amlodipine folic acid 5.8mg+standard antihypertensive therapy
  • Amlodipine+intensive antihypertensive therapy
  • Amlodipine+standard antihypertensive therapy
Record updated
23 December 2021

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 35 to 75 with high blood pressure and cerebral small vessel disease, who also have a raised homocysteine level or a specific MTHFR gene type.

Age
35 to 75 years
Sex
All sexes
Disease stage
Cerebral small vessel disease shown on head MRI/CT: a lacunar infarction 7 days to 1 year old, or white matter hyperintensity (Fazekas score 2 to 4), or Fazekas score 1 with an old lacunar infarction. Recorded history of hypertension with systolic blood pressure 130-180 mm Hg, depending on the number of medications. mRS score of 2 or less.
Earlier treatment
Cannot have used vitamin supplements containing folic acid, B6 or B12, or folic acid antagonists such as methotrexate, in the last 3 months. Cannot have had heart, brain or kidney revascularization or other aortic stenting.
Biomarker or test result
Serum Hcy of 10 µmol/L or more, or MTHFR 677 TT genotype.

Main reasons for not taking part

  • Secondary hypertension
  • Narrowing of arteries in the head or neck (50% or more with symptoms, 70% or more without)
  • Dialysis, stage 4-5 chronic kidney disease, or eGFR below 30 mL/min/1.73m²
  • Pregnant or breastfeeding women, or women planning pregnancy
  • Epilepsy or use of anti-epileptic medication

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Age 35-75 years
  • Meets any of the following criteria:
  • Lacunar infarction occurring within the period of seven days up to one year post-infarction, diagnosed by head MRI/CT (meeting modified Fisher criteria*); 2）Head MRI indicating white matter hyperintensity, 4≥Fazekas score*≥2; 3）Head MRI indicating white matter hyperintensity, Fazekas=1, combined with old subcortical vascular lacunar infarction
  • For modified Fisher criteria and Fazekas score, see FAITH main study appendix 1 and appendix 6); Medical recorded history of hypertension. Systolic blood pressure SBP: 130-180 mm Hg on 0 or 1 medication SBP: 130-170 mm Hg on up to 2 medications SBP: 130-160 mm Hg on up to 3 medications. 4. mRS score ≤2; 5. Serum Hcy ≥10 µmol/L or MTHFR 677 TT genotype; 6. Signed informed consent form

Who cannot take part

  • Patients who have previously taken candesartan or other angiotensin receptor antagonist (ARB) type medication, indapamide or other similar diuretic type medication, or any medication or health product containing folic acid, and reported adverse reactions
  • History of epilepsy or currently using anti-epileptic medication
  • Patients with secondary hypertension
  • Patients who have undergone revascularization of the heart, brain, or kidney, or other aortic stenting procedures
  • Patients who have indicators for specific antihypertensive medications (e.g. β-blockers after acute myocardial infarction, RAS blockers for prevention of cardiovascular disease, α-blockers for treatment of benign prostate hyperplasia)
  • Patients undergoing dialysis or with stage 4-5 chronic kidney disease, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m²
  • Symptomatic intracranial and extracranial artery stenosis (stenosis ≥50%), or asymptomatic intracranial and extracranial artery stenosis (stenosis≥70%)
  • Any symptoms of orthostatic hypotension when measuring standing blood pressure, or if standing SBP <110mmHg
  • Bilateral renal artery stenosis
  • Within the last three months, regular usage of vitamin supplements containing folic acid, B6, or B12, or usage of folic acid antagonists (e.g. methotrexate)
  • Pregnant and lactating women, or women planning to become pregnant
  • Life expectancy less than four years
  • Within the last month, participation in another clinical trial
  • Any patient determined by the researchers to be unsuitable for the present study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 35 and 75 years old?

Where in China

  • Beijing Tiantan HospitalBeijing, ChinaContact: Jinglin MoNo longer taking part

About the trial

What the trial wants to find out

The primary objectives of this trial are:

Read full original descriptionShow less

1. Efficacy evaluation of amlodipine folic acid tablets:

To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level. 2. Intensive Antihypertensive Therapy:

To assess the effect of intensive antihypertensive therapy (SBP<130 mmHg) versus standard antihypertensive therapy (SBP 130-<140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.

The 4 groups in the trial

  • Amlodipine folic acid 5.8mg+intensive antihypertensive therapyExisting treatment, for comparison

    This group will receive intensive antihypertensive therapy (systolic blood pressure(SBP) \<130 mmHg); with amlodipine folic acid 5.8mg.

  • Amlodipine folic acid 5.8mg+standard antihypertensive therapyExisting treatment, for comparison

    This group will receive standard antihypertensive therapy (SBP: 130-140 mmHg); with amlodipine folic acid 5.8mg.

  • Amlodipine+intensive antihypertensive therapyExisting treatment, for comparison

    This group will receive intensive antihypertensive therapy (systolic blood pressure(SBP) \<130 mmHg); with amlodipine 5.0mg.

  • Amlodipine+standard antihypertensive therapyPlacebo, for comparison

    This group will receive standard antihypertensive therapy (SBP: 130-140 mmHg); with amlodipine 5.0mg.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Folic Acid and Intensive Antihypertensive Therapy for Cerebrovascular and Cardiovascular Events Prevention Among Patients With Hypertension and Cerebral Small Vascular Diseases (FAITH)----A Multicenter, Randomized, Controlled, Open-label, 2x2 Factorial, Blinded End-point Trial
Plain-language title
Folic acid and tighter blood pressure control in brain small vessel disease with hypertensionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05169021, who can take part
Record updated
23 December 2021