NCT Number: NCT00159627
Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are refractory to high dose diuretic therapy.
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Stanford, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- History of CHF for greater than 3 months,
- Receiving oral/IV diuretic therapy
- Hospitalized for therapy for HF and edema that has not responded to diuretic therapy.
- Signs and symptoms of ongoing volume overload
Exclusion criteria
- Myocardial infarction in past 14 days
- Clinical evidence of acute coronary syndrome causing worsening of HF,
- Pregnant or breast-feeding,
- Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
- Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days,
- Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
- Deterioration due to an acute or superimposed condition requiring therapy other than diuretics
- Symptomatic ventricular tachycardia,
- Severe concomitant primary hepatic disease,
- Severe pulmonary disease,
- Any other concomitant life-threatening disease,
- CVA in the preceding 6 months,
- Hypotension,
- Participated in another clinical trial within 30 days,
- Acute contrast nephropathy,
- Admitted for heart transplant surgery or have had a heart transplant.
Treatment and study plan
Primary outcomes
-
Change in urine volume from baseline
Sponsors and collaborators
Lead sponsor
NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Industry
Collaborators
- Merck Sharp & Dohme LLC
Registry information
Official study title
A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of the Effects of KW-3902 on Diuresis in Patients With Congestive Heart Failure (CHF) Refractory to High Dose Diuretic Therapy
Important dates
- Study start
- 2004
- First posted
- Sep 12, 2005
- Registry last updated
- Jan 29, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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