Overview
H-Type Hypertension Precision Medicine Trial
Status:
Unknown status
Unknown status
Trial end date:
2019-06-30
2019-06-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a multicenter, randomized, double-blind, controlled clinical trial. It aims to investigate the effects of different doses of folic acid on lowering homocysteine (Hcy) in patients with hypertension with different genotypes of MTHFR C677T and to determine a dose-response relationship. This study consists of 3 phases: screening ( 2-10 days ), run-in period (0-2 weeks), and double-blind treatment (8 weeks). Follow-up visits will take place at the beginning of both the run-in period and the double-blind treatment period, and at the end of the 2nd, 4th, 6th, and 8th weeks. Hypertensive patients demonstrating good tolerance and adherence to angiotensin converting enzyme inhibitor (ACEI) drugs and who have already been genotyped for MTHFR C677T polymorphism may pass over the run-in period and directly enter the double-blind randomized treatment period. No medications that could affect the assessment of efficacy may be taken during any stage of the study.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shenzhen Ausa Pharmed Co.,LtdCollaborators:
Anqing Research Center of Anhui Medical University Biomedical Institute
Nanfang Hospital of Southern Medical University
Peking University First Hospital
People's Hospital of Rongcheng
Second Affiliated Hospital of Nanchang University
Shenzhen Evergreen Medical Institute
The First People's Hospital of LianyungangTreatments:
Enalapril
Enalaprilat
Folic Acid
Maleic acid
Vitamin B Complex
Criteria
Inclusion Criteria for run-in period:- (1)≥ 45 years old;
- (2)A diagnosis or previous diagnosis of essential hypertension, including anyone
currently taking antihypertensive drugs; or for those who have not taken
antihypertensive drugs within the last 2 weeks, two consecutive examinations were
conducted at least one day apart, and both sitting blood pressure (mean value of 3
measurements) met the following criteria: diastolic blood pressure (DBP) ≥90 mmHg or
systolic blood pressure (SBP) ≥140 mmHg (the second blood pressure was measured at
V1);
- (3)If a study participant is a woman of childbearing age, she agrees to use a reliable
contraceptive method during the trial;
- (4)Voluntarily participates and has signed an informed consent form.
Inclusion Criteria for Double-Blind Treatment Period:
- (1)Completed MTHFR C677T gene polymorphism detection in run-in period or MTHFR C677T
genotype already known in advance;
- (2)Exhibited good tolerance to enalapril and good overall medication compliance (>80%)
in run-in period or previously exhibited good tolerance and adherence to ACEI drugs in
previous medication history.
- (3)Voluntarily continues to participate in this study.
Exclusion Criteria:
Participants meeting any of the following criteria may not participate in this study:
- (1)Women who are pregnant and/or lactating; or women who intend to conceive within a
year;
- (2)History of allergies to enalapril, folic acid or other components of the compound
drug;
- (3)History of adverse reactions or intolerance to enalapril or other ACE inhibitors,
or drugs or supplements containing folic acid;
- (4)Diagnosis or suspicion of secondary hypertension;
- (5)Known serious medical conditions, including: Cardiovascular: patients with
clinically diagnosed cardiac dysfunction (NYHA class III and above), hypertrophic
obstructive cardiomyopathy, clinically significant valvular heart disease, acute
coronary syndrome within the last 3 months, or percutaneous coronary intervention
(PCI), or coronary artery bypass graft (CABG); or abnormal pre-enrollment ECG test
results with clinically significant arrhythmias (atrial flutter, atrial fibrillation,
grade II-III atrioventricular block, etc.); Digestive: a previous diagnosis of various
types of viral hepatitis that are still in the active phase; abnormal pre-enrollment
liver function test results (ALT, AST, GGT, TBIL, or DBIL 3 times higher than normal,
ALB ≤ 30g/L); gastrectomy and/or gastrojejunostomy; gastrointestinal dysfunction;
Urinary: pre-enrollment serum creatinine greater than 200μmol/L; clinical diagnosis of
renal artery stenosis, isolated kidney, kidney transplantation and/or other diseases;
Endocrine: type 1 diabetes or uncontrolled type 2 diabetes (fasting blood glucose
above 11.1 mmol/L at pre-enrollment); previous diagnosis of hyperthyroidism and
failure to correct; Respiratory: pulmonary heart disease; chronic obstructive
pulmonary disease; Neuropsychiatric: recent transient ischemic attack or stroke
(within the last 3 months); peripheral or severe autonomic dysfunction; mental or
nervous system dysfunction, inability to express desire; known drug or alcohol
dependence; Malignancy, malnutrition, hematopoietic disorders and other serious
diseases.
- (6)Significant signs of abnormalities as seen in laboratory tests or physical
characteristics, which, at the discretion of the investigators, indicates that the
patient is experiencing a serious illness or, may affect the observation and
evaluation of the drug's efficacy or adverse events, or renders the patient unsuitable
for participating in this study;
- (7)Patients currently taking folate, B12, or B6, or any compounds containing them, who
express an inability or a refusal to stop usage;
- (8)Regular usage of folic acid supplements or compounds containing folic acid in the
past 3 months;
- (9)Participation in a clinical trial for a drug that has not yet been officially
approved for marketing within one month prior to the first visit.