A Phase 2 interventional study of Exercise capacity VO2 max determination and Standardized meals in Healthy and Pre Hypertension, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by University of Alabama at Birmingham · Phase 2, Interventional, and Other
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.
The heart is an endocrine organ. The natriuretic peptides are hormones produced in the heart and are secreted in response to increased wall stress in atria and ventricles. The principal circulating NPs are Atrial Natriuretic Peptide (ANP) and B-type Natriuretic Peptide (BNP). The endocrine actions of NPs are natriuresis and dilatation of peripheral arteries.
The NPs concentrations are elevated in heart failure (HF) and hypertension (HTN) due to volume and pressure overload. Therefore, NPs are used as diagnostic and prognostic markers in heart failure. However, NPs role in healthy individuals is not known.
Previous studies have shown that reduced NP levels are associated with a greater risk of HTN. Moreover, African-Americans have lower resting NP levels than Caucasians. We hypothesize that relative NP deficiency in African American compared to Caucasian has the potential to contribute to increase risk of all-cause mortality, HTN, HF and its sequelae.
Evidence from multiple clinical trials has positioned beta-blockers as a standard heart failure therapy. Beta-blocker therapy leads to increased NP levels and suppression of Renin-aldosterone-angiotensin system (RAAS) system. Suppression of renin levels by beta-blockers has been shown as a potential mechanism of benefit in HF. However, study shows that beta-blockers are less effective in African-Americans compared to Caucasians in HF treatment. So, the investigators have proposed a pilot study to look for race-based differences in the NP and RAAS response to metoprolol in healthy individuals.
Additionally, exercise has been reported to increase NP levels. ANP increases more than BNP with exercise. But there is no data of NP changes in African-American with exercise. So the investigators have proposed a sub-study of race-based difference in ANP and BNP response to exercise.
40 African-American and 40 Caucasians normotensive or pre-hypertensive (healthy) individuals will be enrolled.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 80 is above the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Other: Exercise capacity VO2 max determination · Dietary Supplement: Standardized meals · Other: Exercise challenge · Drug: Metoprolol Succinate ER
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Other: Exercise capacity VO2 max determination · Dietary Supplement: Standardized meals · Other: Exercise challenge · Drug: Metoprolol Succinate ER
Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
Change in Plasma BNP After 6-weeks of Beta-Blocker
Mean percentage change in plasma BNP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
Time frame: 6 weeks
Change in Plasma NT-proBNP After 6-weeks of Beta-Blocker
Mean percentage change in plasma NT-proBNP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
Time frame: 6 weeks
Change in Plasma MR-proANP After 6-weeks of Beta-Blocker
Mean percentage change in plasma MR-proANP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
Time frame: 6 weeks
Change in Plasma BNP After Standardized Exercise Challenge
Mean percentage change in plasma BNP concentrations in response to exercise
Time frame: Mean percentage change in plasma BNP concentrations from baseline to 20 minutes post-exercise (immediately after exercise)
Change in Plasma NT-proBNP After Standardized Exercise Challenge
Mean percentage change in plasma NT-proBNP concentrations in response to exercise
Time frame: Mean percentage change in plasma NT-proBNP concentrations from baseline to 20 minutes post-exercise (immediately after exercise)
Change in Plasma MR-proANP After Standardized Exercise Challenge
Mean percentage change in plasma MR-proANP concentrations in response to exercise
Time frame: Mean percentage change in plasma MR-proANP concentrations from baseline to 20 minutes post-exercise (immediately after exercise)
| Milestone | Black Participants | White Participants |
|---|---|---|
| Started | 40 | 40 |
| Completed | 40 | 40 |
| Not completed | 0 | 0 |
Mean percentage change in plasma BNP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
| Percentage Change in Plasma BNP levels | Black Participants | White Participants |
|---|---|---|
| Change in Plasma BNP After 6-weeks of Beta-Blocker | 45 (7 to 95) | 74 (30 to 133) |
Mean percentage change in plasma NT-proBNP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
| Percentage Change in Plasma NT-proBNP | Black Participants | White Participants |
|---|---|---|
| Change in Plasma NT-proBNP After 6-weeks of Beta-Blocker | 95 (31 to 190) | 99 (35 to 193) |
Mean percentage change in plasma MR-proANP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
| Percentage Change in Plasma MR-proANP | Black Participants | White Participants |
|---|---|---|
| Change in Plasma MR-proANP After 6-weeks of Beta-Blocker | 18 (-5 to 47) | 16 (-6 to 44) |
Mean percentage change in plasma BNP concentrations in response to exercise
| Percentage change in Plasma BNP | Black Participants | White Participants |
|---|---|---|
| Change in Plasma BNP After Standardized Exercise Challenge | 59 (14 to 114) | 61 (20 to 116) |
Mean percentage change in plasma NT-proBNP concentrations in response to exercise
| Percentage change in Plasma NT-proBNP | Black Participants | White Participants |
|---|---|---|
| Change in Plasma NT-proBNP After Standardized Exercise Challenge | 11 (-28 to 69) | 23 (20 to 87) |
Mean percentage change in plasma MR-proANP concentrations in response to exercise
| Percentage change in Plasma MR-proANP | Black Participants | White Participants |
|---|---|---|
| Change in Plasma MR-proANP After Standardized Exercise Challenge | 35 (8 to 68) | 43 (15 to 78) |
Collected over Adverse events were collected after the completion of the screening visit, during the exercise visits, and during the Beta-Blocker intervention period for a total of 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Black Participants | 0/40 (0%) | 0/40 (0%) | 6/40 (15%) |
| White Participants | 0/40 (0%) | 0/40 (0%) | 7/40 (17.5%) |
| Event | Black Participants | White Participants |
|---|---|---|
| HeadacheNervous system disorders | 6/40 | 7/40 |
| NauseaGastrointestinal disorders | 5/40 | 6/40 |
| Vasovagal ResponseNervous system disorders | 2/40 | 3/40 |
| Age, Continuous(years) | Black Participants | White Participants | Total |
|---|---|---|---|
| Median | 27 (22 to 32) | 25 (20 to 30) | 26 (21 to 30) |
| Sex: Female, Male(Participants) | Black Participants | White Participants | Total |
|---|---|---|---|
| Female | 21 | 19 | 40 |
| Male | 19 | 21 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Black Participants | White Participants | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 40 | 40 | 80 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body Mass Index (BMI)(kg/m²) | Black Participants | White Participants | Total |
|---|---|---|---|
| Median | 25.1 (22.4 to 27.7) | 24.1 (22.4 to 26.8) | 24.5 (22.4 to 27.6) |
| Systolic Blood Pressure (SBP)(mmHg) | Black Participants | White Participants | Total |
|---|---|---|---|
| Median | 109 (105 to 116) | 108 (102 to 116) | 109 (103 to 117) |
| Diastolic Blood Pressure (DBP)(mmHg) | Black Participants | White Participants | Total |
|---|---|---|---|
| Median | 67 (64 to 74) | 70 (63 to 75) | 69 (63 to 75) |
| Heart Rate(beats per minute) | Black Participants | White Participants | Total |
|---|---|---|---|
| Median | 69 (63 to 77) | 70 (62.7 to 79) | 70 (63 to 78) |
| Fasting Glucose(mg/dL) | Black Participants | White Participants | Total |
|---|---|---|---|
| Median | 83.0 (80.0 to 89.0) | 86.5 (79.0 to 90.0) | 85.0 (80.0 to 90.0) |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Metoprolol
University of Alabama at Birmingham →