CompletedPhase 3

PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function

1,102 participantsStarted 2006-10

Plain-language summary

The study is being conducted to examine whether KW-3902IV will result in greater improvement in signs and symptoms of heart failure, with less treatment failure than standard therapy, when it is added to IV loop diuretics in subjects with acute heart failure syndrome and renal impairment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed
✓. Hospitalized for acute heart failure syndrome requiring IV diuretic therapy.
✓. Impaired renal function

Exclusion criteria

✕. Acute contrast induced nephropathy
✕. Ongoing or planned IV therapy for heart failure with positive inotropic agents, vasopressors, vasodilators, or mechanical support with the exception of IV nitrates
✕. BNP \<500 pg/mL or NT-pro-BNP \<2000 pg/mL
✕. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis
✕. Severe pulmonary disease
✕. Significant stenotic valvular disease
✕. Heart transplant recipient or admitted for cardiac transplantation
✕. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening

What they're measuring

effect on heart failure signs and symptoms

Timeframe: 3 Days

effect on renal function

Timeframe: 3 Days

Trial details

NCT IDNCT00354458

SponsorNovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-07

View on ClinicalTrials.gov More Heart Failure, Congestive trials