Phase 3
Completed N=26
24 Hour Ambulatory Cardiac Oxygen Consumption
Source: ClinicalTrials.gov NCT05170061 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) — 2531; 2824; 2484 mmHg*beats/min — p=0.05
◆ Published Evidence
Emerging
16citations · ~1 / year
Ambulatory 24-hour cardiac oxygen consumption and blood pressure-heart rate variability: effects of nebivolol and valsartan alone and in combination.
Summary
A randomized,double-blind, active controlled,15 week study to evaluate the effects of nebivolol and valsartan alone and in combination on 24-hour ambulatory cardiac work and variability of heart rate-mean central systolic pressure product.
Linked Publications
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Ambulatory 24-hour cardiac oxygen consumption and blood pressure-heart rate variability: effects of nebivolol and valsartan alone and in combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) |
2531; 2824; 2484 | 0.05 |
| SECONDARY Cuff SBP |
150; 148; 146 | 0.05 |
| SECONDARY Cuff DBP |
84; 87; 81 | 0.05 |
| SECONDARY Ambulatory Brachial Double Product |
9329; 11239; 9154 | 0.05 |
| SECONDARY Ambulatory Mean Heart Rate |
64; 77; 63 | 0.05 |
| SECONDARY Ambulatory Mean Central Diastolic BP |
91; 90; 89 | 0.05 |
| SECONDARY 24-hour Brachial Systolic BP |
147; 143; 145 | 0.05 |
| SECONDARY 24-hour Brachial Diastolic BP |
89; 88; 87 | 0.05 |
| SECONDARY Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI) |
2482; 2817; 2423 | 0.05 |
| SECONDARY Nighttime ACRPP |
2454; 2564; 2309 | 0.05 |
| SECONDARY Daytime Heart Rate |
64; 81; 64 | 0.05 |
| SECONDARY Nighttime Heart Rate |
64; 74; 63 | 0.05 |
| SECONDARY Daytime Central Systolic Pressure |
138; 135; 136 | 0.05 |
| SECONDARY Nighttime Central Systolic Pressure |
135; 130; 131 | 0.05 |
| SECONDARY Daytime Brachial Systolic Pressure |
149; 146; 147 | 0.05 |
| SECONDARY Nighttime Brachial Systolic Pressure |
145; 138; 141 | 0.05 |
| SECONDARY Daytime Central Diastolic Pressure |
93; 93; 92 | 0.05 |
| SECONDARY Nighttime Central Diastolic Pressure |
89; 86; 85 | 0.05 |
| SECONDARY Daytime Brachial Diastolic Pressure |
91; 91; 89 | 0.05 |
| SECONDARY Nighttime Brachial Diastolic Pressure |
87; 83; 83 | 0.05 |
| SECONDARY Ambulatory Daytime Brachial Rate-pressure Product |
9528; 11869; 9335 | 0.05 |
| SECONDARY Ambulatory Nighttime Brachial Rate-pressure Product |
9284; 10338; 8830 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Subjects with chronic hypertension, treated or untreated
- Males and females, 18 years or older
- Seated clinic systolic BP 145-184 mmHg inclusive or
- Seated clinic diastolic BP 92-119 mmHg, inclusive.
Exclusion Criteria
- Subjects with any of the following conditions will be excluded:
- Any acute or chronic medical condition that, in the judgment of the investigator, renders the subject unable to complete the study, would interfere with optimal participation in the study, or cause significant risk to the subject
- Concomitant or probable need for treatment with other cardiovascular or antihypertensive drugs that may affect blood pressure or influence the effects of study drugs, (e.g. NSAIDs, beta-agonist inhalers therapy for bronchospastic asthma, diuretics); other stable chronic medications that have little effect on study drugs (e.g. diabetes medications, hormone replacements, chronic pain medications. osteoporosis drugs, vitamins, cholesterol drugs, etc.) are permitted if continued at stable doses throughout study.
- History of clinically significant adverse events with beta-blocker or angiotensin-receptor blocker
- Known or suspected secondary hypertension (e.g., renovascular hypertension, primary hyperaldosteronism, etc.)
- Known ischemic heart disease requiring continuous beta-blocker therapy (includes angina, prior transmural myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty or stenting within 6 months prior to study entry).
- Dilated cardiomyopathy (NYHA Functional Class III-IV)
- Clinically significant valvular heart disease or obstructive hypertrophic cardiomyopathy
- Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter), pre-excitation syndrome, second or third degree atrioventricular block, other conduction defects necessitating the implantation of a permanent cardiac pacemaker, or sick sinus syndrome.
- Chronic kidney disease (serum creatinine >2.5 mg/dL)
- Uncontrolled diabetes mellitus (hemoglobin A1c > 10%)
- History of alcohol or other drug abuse within 6 months prior to enrollment
- Positive pregnancy test or failure to practice adequate contraception in women of child-bearing potential
Data sourced from ClinicalTrials.gov (NCT05170061) and the linked publication. 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. Informational only — not medical advice.