Phase 3
Completed N=30
Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril
Source: ClinicalTrials.gov NCT00657241 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Difference in Resting CTTI Between Carvedilol CR (Beta-blocker) and Valsartan (ARB) in Combination With Lisinopril. — 2447; 2500 CTTI units (mmHg*beats/min) — p=<0.05
◆ Published Evidence
Emerging
10citations · ~1 / year
Differences in mean and variability of heart rate and ambulatory rate-pressure product when valsartan or carvedilol is added to lisinopril.
Summary
14-week single blind, double baseline, forced-titration, cross-over comparison of the cardiac benefits of Coreg CR compared to valsartan added to existing ACE inhibition
Linked Publications
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Differences in mean and variability of heart rate and ambulatory rate-pressure product when valsartan or carvedilol is added to lisinopril.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Resting CTTI Between Carvedilol CR (Beta-blocker) and Valsartan (ARB) in Combination With Lisinopril. |
2447; 2500 | <0.05 sig |
| SECONDARY Heart Rate (Beats/Min) |
75; 68 | — |
| SECONDARY Stroke Volume (SV) |
77; 76 | 0.05 |
| SECONDARY Cardiac Output |
5.7; 5.1 | 0.05 |
| SECONDARY Systemic Vascular Resistance |
1407; 1591 | 0.05 |
| SECONDARY Central Systolic Blood Pressure |
130; 141 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Subjects with residual (uncontrolled) hypertension on lisinopril monotherapy, defined as 24-hour ambulatory diastolic BP >85 mmHg.
Exclusion Criteria
A subject meeting any of the following conditions will be excluded from the study:
- History of serious adverse effects with ACE inhibitor, Coreg, or valsartan
- Known or suspected causes of secondary hypertension (e.g., renovascular stenosis, primary hyperaldosteronism)
- Known ischemic heart disease requiring 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).
- Heart failure (NYHA Functional Class II-IV)
- Obstructive 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 AV block, other conduction defects necessitating the implantation of a permanent cardiac pacemaker, or sick sinus syndrome.
- Chronic kidney disease (serum creatinine >2.5 within past 6 months)
- Uncontrolled diabetes mellitus (i.e., a fasting blood glucose >200 mg/dL [>11.1 mmol/L] or hemoglobin A1c > 10%
- History of alcohol or other drug abuse within 6 months prior to enrollment
- Concomitant treatment or probable need for treatment with prohibited medications. NSAIDs, diabetes medications and other chronic meds are permitted if continued throughout study without dosage change.
- Any other medical condition which renders the subject unable to complete the study or which would interfere with optimal participation in the study or produce a significant risk to the subject
- Those with persistent systolic BP elevations above 179 mmHg will be discontinued from the study as will those with any significant adverse effect of medication.
- Positive pregnancy test or failure to practice adequate contraception in women of child-bearing potential
- Bronchospastic asthma requiring chronic steroid or inhaler therapy
- Any women with child-bearing potential
Data sourced from ClinicalTrials.gov (NCT00657241) 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.