Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 10-000342
    NCT ID: NCT01132846
    Sponsor Protocol Number: ROSE

About this study

The purpose of this study is to determine the benefits and safety of intravenous administration of low dose nesiritide or low dose dopamine in patients with congestive heart failure and kidney dysfunction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

This study has been completed

Inclusion Criteria

  • A diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
  • Prior clinical diagnosis of heart failure must be identified within 24 hours of hospital admission (24 hour clock begins when the admission orders are placed)
  • Estimated GFR of > 15 but < 60 mL/min/1.73m2 determined by the MDRD equation
  • Male or female
  • Age ≥ 18 years
  • Willingness to provide informed consent
  • Ability to have a PICC or central line placed (if needed) within 12 hours of randomization and study drug infusion started
  • Anticipated hospitalization of at least 72 hours

Exclusion Criteria

  • Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
  • Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization
  • Systolic BP <90 mmHg
  • Hemoglobin (Hgb) < 9 g/dl
  • Renal replacement therapy
  • History of renal artery stenosis > 50%
  • Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks
  • Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or anginal equivalent)
  • Active myocarditis
  • Hypertrophic obstructive cardiomyopathy
  • Greater than moderate stenotic valvular disease
  • Restrictive or constrictive cardiomyopathy
  • Complex congenital heart disease
  • Constrictive pericarditis
  • Non-cardiac pulmonary edema
  • Clinical evidence of digoxin toxicity
  • Need for mechanical hemodynamic support
  • Sepsis
  • Terminal illness (other than HF) with expected survival of less than 1 year
  • Previous adverse reaction to the study drugs
  • Use of IV iodinated radiocontrast material in last 72 hours or planned during hospitalization
  • Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
  • Inability to comply with planned study procedures
  • Pregnancy or nursing

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Margaret Redfield, M.D.

Closed for enrollment

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CLS-20311335

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