Phase 2
N=80
Race, Natriuretic Peptides and Physiological Perturbations
Healthy · Pre Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03070184 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Plasma BNP After 6-weeks of Beta-Blocker — 45; 74 Percentage Change in Plasma BNP levels
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exercise capacity VO2 max determination (Other); Standardized meals (Dietary_supplement); Exercise challenge (Other); Metoprolol Succinate ER (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma BNP After 6-weeks of Beta-Blocker |
45; 74 | — |
| PRIMARY Change in Plasma NT-proBNP After 6-weeks of Beta-Blocker |
95; 99 | — |
| PRIMARY Change in Plasma MR-proANP After 6-weeks of Beta-Blocker |
18; 16 | — |
| SECONDARY Change in Plasma BNP After Standardized Exercise Challenge |
59; 61 | — |
| SECONDARY Change in Plasma NT-proBNP After Standardized Exercise Challenge |
11; 23 | — |
| SECONDARY Change in Plasma MR-proANP After Standardized Exercise Challenge |
35; 43 | — |
Summary
The purpose of the study is to understand the origins of differential response to beta-blockers in African-Americans and may provide insight regarding racial differences in cardiovascular risk.
Eligibility Criteria
Inclusion Criteria
- 18 to 40 years
- Blood pressure less than 140/90 mm Hg
- Able to perform exercise capacity test
- BMI 18-30 kg/m2
- Willing to adhere to study drug
Exclusion Criteria
- History of cardiovascular disease or use of medications for CVD
- History of hypertension or use of BP lowering medications
- Blood pressure less than 100/60 mm Hg
- Heart rate less than 60 beats/min
- Depression
- Diabetes or use of anti-diabetic medications
- Renal disease (eGFR < 60ml/min/1.73m2)
- Current or prior smokers
- Pregnant or use of Hormone Replacement Therapy (HRT) or oral contraceptives (OCP) or steroids
Data sourced from ClinicalTrials.gov (NCT03070184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.