What this study is
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.
What's being tested
- Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet
Intervention · DRUG
The subject will be randomized, in a double-blind manner to sacubitril/valsartan 49/51 mg once in the morning or once in the evening for a period of 28 days.
- Valsartan 80 mg Oral Tablet
Intervention · DRUG
The subject will be randomized, in a double-blind manner to valsartan 80 mg once in the morning or once in the evening for a period of 28 days.
Study details
- Official title
- Natriuretic Peptide-Renin-Angiotensin-Aldosterone System Rhythm Axis and Nocturnal Blood Pressure
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Obesity · Cardiovascular Diseases · Hypertension · Nocturnal Blood Pressure · Natriuretic Peptides · Renin-Angiotensin-Aldosterone System
- Enrolling
- 160 people
- Starts
- 2022-02-18
- Est. completion
- 2027-01-01
- Design
- Quadruple-blind, randomized, factorial, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Nehal Vekariya, MS · Contact205-934-7173nvekariya@uabmc.edu
- Pankaj Arora, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB-300007789
Principal investigator
Pankaj Arora, MD, FAHA
University of Alabama at Birmingham
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.