Phase 2 N=14 Randomized Single-blind Basic Science

The Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01996449 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2022

Primary outcome: Primary: Muscle Sympathetic Nerve Activity at Rest — 41; 43.8 bursts/minute

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Eplerenone (Drug); Amlodipine (Drug); Microneurography (Procedure); Rhythmic handgrip exercise (Procedure); Sustained hand grip (Procedure); Forearm blood flow (Procedure); Arm cycling exercise (Procedure); Cold Pressor test (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Muscle Sympathetic Nerve Activity at Rest	41; 43.8	—
SECONDARY Muscle Sympathetic Nerve Activity During Exercise	47; 51	—

Summary

Hypertensive patients often show an exaggerated rise in blood pressure during exercise through overactivity of the exercise pressor reflex. An increasing body of evidence suggests a role for aldosterone in augmenting the exercise pressor reflex in hypertensive humans. We hypothesize that this effect of aldosterone is mediated by its direct action on the central nervous system and that administration of mineralocorticoid receptor antagonists constitute an effective treatment for EPR overactivity in hypertension, independent of reductions in resting BP.

Eligibility Criteria

Inclusion Criteria

Experiments will be performed on 3 groups of nondiabetic human subjects:
1) stage I (140-159/90-99 mmHg) subjects with essential hypertension.
2) stage I hypertensive subjects with primary aldosteronism
3) normotensive controls.

Exclusion Criteria

1) Any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic dysfunction by echocardiography.
2) Blood pressure averaging ≥160/100 mmHg
3) Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2
4) Diabetes mellitus or other systemic illness
5) Pregnancy
6) Hypersensitivity to nitroprusside, phenylephrine, amlodipine or eplerenone
7) Any history of substance abuse or current cigarette use
8) Any history of psychiatric illness
9) History of malignancy

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Data sourced from ClinicalTrials.gov (NCT01996449). 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.