Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
Status and phase
Completed
Phase 2
Conditions
Heart Failure, Congestive
Treatments
Drug: tolvaptan
Details and patient eligibility
About
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
Enrollment
140 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosed with Class III or IV heart failure for at least 3 months
- Left ventricular ejection fraction less than or equal to 40%
- Currently being treated for heart failure with standard therapies for at least one month
Exclusion criteria
- Women who are pregnant or breastfeeding
- Inability to take oral medications
- Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
- Hypertrophic obstructive cardiomyopathy
- Severe obstructive pulmonary disease
- Significant renal impairment
- Significant uncorrected valvular or congenital heart disease
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
31
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Data sourced from clinicaltrials.gov
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