Morning or evening? study tests best time for BP meds in obesity
NCT ID NCT04971720
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether taking blood pressure medication in the morning or evening works better for obese people with high nighttime blood pressure. Obese individuals often have disrupted natural rhythms that raise their heart disease risk. Researchers will give 160 participants either sacubitril/valsartan or valsartan at different times of day for 28 days to see which timing better restores normal blood pressure patterns.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sacubitril/Valsartan and Valsartan
- What this could lead to
- If successful, this could show that timing blood pressure medication to match the body's natural rhythms improves nighttime blood pressure control in obese individuals, potentially reducing their heart disease risk.
- What could go wrong
- This is a small, early-phase study with only 160 participants over 28 days. The results may not apply to all obese individuals, and the benefit of timing may be modest or not clinically significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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