For
additional information regarding any of these clinical trials,
please contact our research coordinators Julie Sorg (pager
92977) and Virginia Erickson (pager 90319) or call x58816.
Stamina-HeFT
Trial: Darbepoetin Alfa Treatment
for Anemia in Heart Failure
The
Study of Anemia in Heart Failure-Heart Failure Trial is a
double-blind, randomized, placebo-controlled, multicenter
study to assess the impact of subcutaneous Darbepoetin
Alfa treatment on exercise tolerance in subjects with
symptomatic congestive heart failure and anemia. The primary
endpoint is a change from baseline to month 6 in exercise
tolerance as measured by treadmill testing. Secondary endpoints
include NHYA Classification, quality of life, global
assessments, and mortality.
Patients
will be randomized 1:1 to receive subcutaneous darbepoetin
alfa (treatment group) or placebo
(control group). Patients will be administered subcutaneous
study drug every two weeks for 54 weeks.
The dose of study drug for the treatment group will be
titrated to gradually achieve and to maintain a
Hb concentration of 14.0 +
1.0 g/dl. Patients
in both groups will have blood drawn every week for 12 weeks, or
until Hb level maintained, and then
every 2 weeks for the duration of the study.
Inclusion:
·
LVEF
< 40%
·
Hb
< 12.5 g/dl
·
Treatment
for CHF with ACE inhibitor and Beta Blocker unless not tolerated
·
Ability
to complete cardiopulmonary exercise testing (treadmill)
Exclusion:
·
CVA,
MI, CABG, angioplasty or unstable angina within last 3 months
·
Uncorrected
valvular disease that requires
surgery
·
Likely
cardiac transplant within 6 months
·
Uncontrolled
ventricular response to atrial
fibrillation or flutter
·
Creatinine
> 3.0 mg/dl
·
Whole
blood or RBC transfusion within 12 weeks of randomization
·
Anemia
that is due to acute or chronic bleeding
PEECH
Trial: Enhanced External Counterpulsation
(EECP) for Heart Failure
EECP
in Heart Failure is a single-blind, controlled, randomized study
to assess the efficacy and safety of EECP in the treatment of
heart failure patients. The
primary objective is to determine whether therapy with EECP
increases exercise capacity in peak oxygen consumption (VO2
max) and maximum exercise duration using a standardized
treadmill. Secondary objectives include an improvement in
quality of life using the Minnesota Living with Heart Failure.
Patients
will be randomized 1:1 to receive EECP (treatment group) or
Usual Care (control group). Depending on randomization, the
study has 40 visits over a 9-month period. There are two visits,
one week apart before treatment and randomization, including an
H&P, blood tests, and exercise testing.
After randomization, patients assigned to the EECP group
will be given 35 treatments occurring over 7 weeks (1 hour
session per day, 5 days per week). Usual care patients will be
treated with standard medical care.
All patients will have an additional 3 visits after the
EECP period, at approximately 3, 6, and 9 months.
Major
Inclusion:
·
Ischemic
or Non-Ischemic cardiomyopathy
·
LVEF
< 35%
·
NYHA
II-IV
·
Use
of ACE-inhibitor for at least 1-month prior to randomization
·
Stable
BB dose for at least 3 months prior to randomization
·
Ability
to complete cardiopulmonary exercise testing
·
Serum
creatinine < 2.5mg/dl
Major
Exclusion:
·
Patients
with Afib, Aflutter, and V-tach
·
Clinically
significant valvular disease
·
History
of DVT, phlebitis, stasis ulcer, PE, AAA
·
ICD
trigger within past 6 months
·
Coagulation
with INR > than 2.0
·
COPD
with forced expiratory volume of < 1.5L.
COMPASS-HF
Trial: Implantable Hemodynamic
Monitor for Heart Failure
Chronicle
Offers Management to Patients with Advanced
Signs and Symptoms of Heart Failure
is a multi-center, randomized, single-blind study to evaluate
the safety and effectiveness of the Chronicle Implantable Hemodynamic
Monitoring (IHM) System. The
Chronicle system is intended to provide clinicians with trends
of hemodynamic pressure data thereby
decreasing the number of heart failure decompensations
and hospital admissions.
All
patients receive the IHM system and are randomized to either the
Total Clinician Access (TCA) group (treatment) or Blocked
Clinician Access (BCA) group (control). Patients in both groups
send weekly hemodynamic data that
can be viewed on the Chronicle website.
Patients randomized to the TCA group will be managed
using Chronicle data, including trended RV, estimated PA
pressure, heart rate, and activity data, whereas subjects
randomized to the BCA group will be treated conventionally.
Chronicle data will be available for all patients after the
6-month study visit. Patients are followed at 1, 3, 6, 12 and
every 6 months until completion of study.
Inclusion:
·
NYHA
III/IV
· Optimal
medical therapy including ACE inhibitor and BB
·
At
least one HF hospitalization or ER visit requiring diuretics
within 6 months prior to baseline
·
Ability
to send weekly data and maintain a weekly activity journal
Exclusion:
·
Severe
COPD
·
Known
atrial or septal
defects, or mechanical heart valves
·
Patients
with cardiac resynchronization that has not reached optimal
programming for 3 months
·
CABG,
CVA, MI, Angioplasty within last 3 months
·
Primary
diagnosis of pulmonary arterial hypertension
·
Serum
creatinine > 3.5
·
Previously
implanted non-compatible pacemaker or ICD
HF-ACTION
Trial: Exercise Training for Heart Failure
Heart
Failure and A Controlled Trial Investigating
Outcomes of Exercise TraiNing
(HF-ACTION) is a multicenter,
international, randomized trial that addresses the primary
hypothesis that patients with left ventricular (LV) systolic
dysfunction and New York Heart Association (NYHA) class II-IV
symptoms who are given exercise training in addition to standard
care will have a ³
20% lower rate of death and hospitalization over two years than
patients who receive usual care alone.
Important secondary endpoints include exercise training
parameters, economics, quality of life, and depression.
Patients
will be randomized in a 1:1 fashion to receive usual care or
usual care plus exercise training.
Patients in the intervention arm will undergo 36
supervised exercise training sessions before initiating a home
exercise training regimen that will be supplemented with
occasional supervised review training sessions.
All patients will perform gas exchange exercise tests at
baseline, 3 months, 12 months, and 24 months of follow up.
All randomized patients will receive follow-up clinic and
telephone calls at pre-specified times.
Inclusion:
·
LVEF
£
35%
·
NYHA
II-IV
·
On
optimal therapy
·
Able
to exercise
Exclusion:
·
Comorbidity
preventing exercise
·
Major
cardiovascular event in last 6 weeks or planned in next 6 months
·
Transplant
within 6 months
·
Regular
exerciser
·
Unable
to perform CPX
·
Fixed
rate pacer
·
Participating
in another clinical trial
