No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Other
Participants needed
160 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for obese adults with high blood pressure. Participants will be involved in research that aims to improve blood pressure treatment timing based on body rhythms.
Are You a Good Fit for This Trial?
Rules you outCardiovascular diseaseAngioedemaAnemia
You may be able to join if
I am 18 years old or older
My BMI is between 30 and 45
My blood pressure is between 130-160 over 80-100
You may not be able to join if
I am under 18 years old
My blood pressure is below 130 or above 160
My BMI is below 30 or above 45
I have a history of pulmonary hypertension
I have had any heart disease in the past
I take 3 or more blood pressure medications
I have significant psychiatric illness
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-n…
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System \[RAAS\]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals.
Trial Locations
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Eligibility 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. Indiv…
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)
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