Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD

Launched by BEIJING TIANTAN HOSPITAL · Dec 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called amlodipine combined with folic acid on patients with hypertension (high blood pressure) who also have cerebral small vessel diseases (CSVD) and elevated homocysteine levels, which can increase the risk of strokes. The trial aims to determine if taking this combination of medication can help prevent strokes better than just amlodipine alone. Additionally, the study will compare two levels of blood pressure control—intensive treatment aiming for a systolic blood pressure below 130 mmHg versus standard treatment aiming for a systolic blood pressure between 130 and 140 mmHg—to see which approach better reduces the risk of heart and brain-related events.

Eligible participants for this trial are adults aged 35 to 75 who have a history of hypertension and meet certain medical criteria related to recent strokes or specific findings on brain scans. Participants will be required to sign an informed consent form before joining the study. While the trial is not yet recruiting, those who join can expect to receive either the new medication or the standard treatment while being closely monitored for any health changes. It’s important to note that some individuals, such as those with certain types of kidney problems or who have taken specific medications in the past, may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 35-75 years;
• 2. Meets any of the following criteria:
• • 1) 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).
• • 3. 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.
• Exclusion Criteria:
• • 1. Patients with secondary hypertension;
• • 2. Symptomatic intracranial and extracranial artery stenosis (stenosis ≥50%), or asymptomatic intracranial and extracranial artery stenosis (stenosis≥70%);
• • 3. Patients who have undergone revascularization of the heart, brain, or kidney, or other aortic stenting procedures;
• • 4. Any symptoms of orthostatic hypotension when measuring standing blood pressure, or if standing SBP \<110mmHg;
• • 5. Bilateral renal artery stenosis;
• • 6. 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;
• • 7. 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);
• • 8. 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);
• • 9. Patients undergoing dialysis or with stage 4-5 chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m²;
• • 10. History of epilepsy or currently using anti-epileptic medication;
• • 11. Pregnant and lactating women, or women planning to become pregnant;
• • 12. Life expectancy less than four years;
• • 13. Within the last month, participation in another clinical trial;
• • 14. Any patient determined by the researchers to be unsuitable for the present study.