|
|
|
|
|
|
Sponsored by: |
Mayo Clinic |
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00587808 |
The guiding hypotheses are that (1) mechanisms in addition to diastolic dysfunction, while normal at rest, are compromised with stress, leading to symptoms of HF, and (2) that an increased proportion of the increase in LV diastolic pressures seen in HFpEF is mediated via exaggerated pericardial/right heart-LV coupling (restraint).
Condition | Intervention |
Heart Failure |
Procedure: RHC with VO2 consumption |
MedlinePlus related topics: | Exercise and Physical Fitness Heart Failure |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Invasive Characterization of the Mechanisms Underlying Exertional Intolerance and Increased Filling Pressures in Patients With Heart Failure and a Preserved EF |
Estimated Enrollment: | 40 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
HFpEF
Patients with a history of HFpEF
|
Procedure: RHC with VO2 consumption
All pressure-volume data is acquired at 250 Hz and stored on the Leycom system for offline analysis. Volume data will be calibrated using the most recent EF from echocardiogram and stroke volume from the Fick method. Measured O2 consumption will be utilized along with sampling of SVC and arterial blood oximetry to determine cardiac output at rest and during exercise
|
control
Patients with a without a history of CHF
|
Procedure: RHC with VO2 consumption
All pressure-volume data is acquired at 250 Hz and stored on the Leycom system for offline analysis. Volume data will be calibrated using the most recent EF from echocardiogram and stroke volume from the Fick method. Measured O2 consumption will be utilized along with sampling of SVC and arterial blood oximetry to determine cardiac output at rest and during exercise
|
Nearly half of all patients with heart failure have a preserved ejection fraction (HFpEF)1-3. This group is increasing in prevalence, has similar morbidity and mortality to systolic HF, and, despite increasing awareness of the healthcare burden, is without proven treatments1. This is related largely to a limited understanding of the basic mechanisms causing the disease3. Recent studies have added to contemporary understanding, but the pathophysiology remains controversial and incompletely understood4-8. A limitation of most prior studies is that the noninvasive measurements employed are merely surrogates for gold standard, invasive hemodynamic assessment9. There is general consensus that HFpEF patients have increased left ventricular filling pressures (LVDP) and relatively normal systolic function at rest5,8,10, but two critical questions remain: what causes the increase in LVDP, and, are there important deficits in the cardiovascular response to exercise stress in HFpEF patients3,4? The current study will resolve these questions by performing comprehensive hemodynamic analysis in HFpEF patients referred to the cardiac cath lab, compared to age and gender matched controls without HF. LV systolic, diastolic, and vascular function will be examined at rest and during graded supine exercise at fixed and varied preload to definitively characterize both baseline differences and discrepancies in cardiovascular reserve function that only become apparent during stress, when HFpEF patients typically become symptomatic11. This study will yield valuable information describing the roles for systolic, diastolic and pericardial abnormalities in the pathogenesis of HFpEF, providing critical preliminary data upon which better targeted therapeutic trials of this common disorder can be based.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
HFpEF subjects (NYHA class ≥II) defined by modified Framingham criteria4 (2 major or 1 major + 2 minor): Major criteria: paroxysmal nocturnal dyspnea or orthopnea, jugular distension or venous pressure>16 mmHg, rales or pulmonary edema, cardiomegaly, hepatojugular reflex, weight loss>4.5 kg in response to diuretics, BNP>400; Minor criteria: ankle edema, nocturnal cough, exertional dyspnea, pleural effusion, HR>120, hepatomegaly, vital capacity<2/3 normal, BNP>200, LA volume index>40cc/m2.
Inclusion Criteria:
Exclusion Criteria:
Contact: Barry A. Borlaug, M.D. | 507-774-1446 | borlaug.barry@mayo.edu |
Contact: Kelly S. Flood, R.N. | 507-255-9524 | flood.kelly@mayo.edu |
United States, Minnesota | |||||
Mayo Clinic | Recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Barry A. Borlaug, M.D. 507-284-1446 borlaug.barry@mayo.edu | |||||
Contact: Kelly S. Flood, R.N. 507-255-9524 flood.kelly@mayo.edu | |||||
Principal Investigator: Barry A. Borlaug, M.D. |
Mayo Clinic |
Principal Investigator: | Barry A. Borlaug, M.D. | Mayo Clinic |
Mayo Clinic Clinical Trials 
  |
Responsible Party: | Mayo Clinic ( Barry A. Borlaug, M.D. ) |
Study ID Numbers: | 07-005202, HFpEF |
First Received: | December 21, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00587808 |
Health Authority: | United States: Institutional Review Board |
|
|
|