Targeting blood pressure rhythms in obese individuals
Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure
This study is testing if giving blood pressure medications at certain times can help people with obesity and high blood pressure feel better and manage their condition more effectively.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04971720 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between natriuretic peptides and blood pressure rhythms in obese individuals, who often experience nocturnal hypertension. It aims to synchronize antihypertensive therapy with the body's natural biological rhythms to improve blood pressure control. The study will utilize medications that enhance natriuretic peptide levels and inhibit the renin-angiotensin-aldosterone system, administered at specific times to optimize their effects. By focusing on the timing of medication, the researchers hope to address the unique challenges faced by obese patients with hypertension.
Who should consider this trial
Good fit: Ideal candidates are obese adults aged 18 and older with specific blood pressure measurements and a body mass index between 30 to 45 kg/m².
Not a fit: Patients with a history of cardiovascular diseases or those taking multiple antihypertensive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood pressure control and reduce cardiovascular risks in obese patients.
How similar studies have performed: While the approach of synchronizing medication with biological rhythms is innovative, similar studies have shown promise in managing hypertension, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age more than or equal to 18 years of age * Body Mass Index between 30 to 45 kg/m\^2 * Blood pressure: Systolic BP more than or equal to 130mmHg and less than or equal to 160mmHg and diastolic blood pressure more than or equal to 80mmHg and less than or equal to 100mmHg. Individuals with hypertension as per the 2017 ACC/AHA Guidelines will be eligible for enrollment Exclusion Criteria: * Age less than 18, at screening. * Systolic BP \<130 or \>160mmHg at baseline, or diastolic BP \<80 or \>100 mmHg at baseline * BMI \<30 kg/m\^2 or \>45 kg/m\^2 * History of pulmonary hypertension * Have any past or present illness of cardiovascular disease including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure. * Participants who are taking 3 or more classes of hypertension medications on the maximum dose or with resistant hypertension * History of angioedema * Estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2 (CKD-EPI equation); urine albumin creatinine ratio ≥30 mg/g * Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal; * Significant psychiatric illness * Anemia (men, Hct \< 38%; women, Hct \<36%) * Participants working night shifts or swing shifts * Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Pankaj Arora, MD, FAHA — University of Alabama at Birmingham
- Study coordinator: Nehal Vekariya, MS
- Email: nvekariya@uabmc.edu
- Phone: 205-934-7173
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.