Using inorganic nitrate to treat high blood pressure in pregnant women
Inorganic Nitrate Supplementation for Blood Pressure Control in Chronic Hypertensive Pregnancies From the 2nd Trimester (NIT_CH): a Triple-Blind Randomized Placebo-Controlled Trial
This study is testing if taking inorganic nitrate can help pregnant women with high blood pressure improve their blood pressure and support their baby's health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Ribeirão Preto, São Paulo) |
| Trial ID | NCT06105775 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of inorganic nitrate supplementation on pregnant women diagnosed with chronic hypertension. Eligible participants will be randomly assigned to receive either a capsule containing inorganic nitrate or a placebo starting from the 16th week of their pregnancy. The study aims to assess the impact of this supplementation on blood pressure and uterine artery health, which are crucial for both maternal and fetal well-being. Participants will continue their standard medications for preeclampsia prophylaxis throughout the study.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with chronic hypertension who are less than 16 weeks gestation and currently on monotherapy with methyldopa.
Not a fit: Patients with uncontrolled chronic hypertension or those with multiple pregnancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer alternative treatment for managing hypertension during pregnancy.
How similar studies have performed: Preliminary studies have shown promising results with inorganic nitrate supplementation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women diagnosed with chronic hypertension (systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg before pregnancy or before 20 weeks of gestation) as defined by the Brazilian Network for Studies on Hypertension in Pregnancy (RBEHG, Brazilian acronym) Protocol and Chronic Hypertension/Preeclampsia by the Brazilian Federation of Gynecology and Obstetrics Associations (FEBRASGO, Brazilian acronym) Protocol. * Patients on monotherapy with methyldopa as treatment at the time of inclusion. * Women with less than 16 weeks of gestation confirmed by first-trimester ultrasonography confirming gestational age. Exclusion Criteria: * Multiple pregnancies, age below 18 years old, inability to provide informed consent, or history of low adherence to medication therapy. * Patients with uncontrolled chronic hypertension, with blood pressure values above 160x110mmHg. * History of food allergies, especially hypersensitivity to beetroot. * Users of illicit drugs, smokers, or alcohol abusers. * Diagnosis of coronary artery disease, congestive heart failure (moderate to severe), moderate to severe liver failure, chronic renal insufficiency (with plasma creatinine clearance less than 30 ml/min/1.73 m² of body surface), pre-existing type 1 diabetes, and type 2 diabetes. * Pregnant women who frequently used non-steroidal anti-inflammatory drugs, nasal decongestants, and anorectics before getting pregnant; users of proton pump inhibitors and H2 receptor antagonists or any other medication that interferes with stomach pH, starting 2 weeks before the beginning and continuing throughout the remainder of the study.
Where this trial is running
Ribeirão Preto, São Paulo
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP — Ribeirão Preto, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Ricardo C Cavalli, Dr — Medical School of Ribeirao Preto, USP
- Study coordinator: Ricardo C Cavalli, Dr
- Email: rcavalli@fmrp.usp.br
- Phone: +55166021000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.